(459 days)
No
The device description focuses on the mechanical components and materials used for bone distraction, with no mention of AI or ML technologies.
Yes
The device is used for bone stabilization and elongation to correct deficiencies or post-traumatic defects, which directly addresses a medical condition to restore function or health.
No
This device is a bone stabilization and elongation system used for correcting deficiencies or defects. It is a treatment device, not one that identifies or diagnoses conditions.
No
The device description explicitly details physical components made of materials like Lactosorb®, stainless steel, and titanium alloy, which are implanted into the body. This indicates a hardware-based medical device, not a software-only one.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that this device is an implantable system used for bone stabilization and elongation through gradual bone distraction. It is surgically placed within the body.
- Intended Use: The intended use describes a surgical procedure to correct bone deficiencies and defects, not a diagnostic test performed on a sample.
- Lack of IVD Keywords: The text does not mention any terms related to laboratory testing, samples, analysis of biological materials, or diagnostic purposes.
Therefore, the Lorenz Resorbable Distraction System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Lorenz Resorbable Distraction System includes devices intended for use in bone stabilization and elongation (lengtheming) I ho corection of oral (alveolar ridge), cranial, and maxillofacial deficiencies or post-traumatic defects require gradual bone with correction. The Lorenz Resorbable System also includes devices intended for use in bone stabilization and elongation (lengthening) when correction of maddibular deficiencies or post-traumatic defects require gradual bone distraction in patients two (2) years old or younger. The mid-face distractor is indicated primarily for LeFort III osteotomies.
Product codes
76 JEY
Device Description
Walter Lorenz Surgical, Inc. manufactures and distributes distraction devices for use in bone stabilization and elongation (lengthening) when correction of oral, cranial, mandibular and maxillofacial deficiencies or post traumatic defects require gradual Each implantable distraction device has a hone distraction. titanium alloy drive screw mechanism and LactoSorb® resorbable connection plates, which are implanted by fixation with LactoSorb® bone screws.
Each device is made from one of the following matcrial(s): LactoSorb®, Titanium 6Al 4V Alloy, ASTM F-136, Stainless Steel, ASTM F-138
LactoSorb® is a resorbable copolymer, a polyester derivative of lactic and glycolic acids. Polylactic/polyglycolic acid copolymer degrades and resorbs IN VIVO by hydrolysis into lactic and glycolic acids that are then metabolized by the body.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral (alveolar ridge), cranial, and maxillofacial bone, mandibular bone, midface
Indicated Patient Age Range
The Lorenz Resorbable System also includes devices intended for use in bone stabilization and elongation (lengthening) when correction of maddibular deficiencies or post-traumatic defects require gradual bone distraction in patients two (2) years old or younger.
Intended User / Care Setting
Operating Surgeon, Physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K971870, K955729, K981666, K974309
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.
0
MAY 1 4 2004
Image /page/0/Picture/1 description: The image contains a sequence of handwritten characters. The sequence appears to be 'K030425'. The characters are written in a simple, slightly irregular style, typical of handwriting. The contrast is high, with dark characters against a light background.
Summary of Safety and Effectiveness
510(k) Summary (per CFR 807-92(c))
Device Name: Lorenz Resorbable Distraction System
Classification Name and Reference: Plate, Fixation, Bone (21 CFR 888.3030), and Screw, Fixation, Bone (21 CFR 888.3040)
Product Code: 76 JEY
Device Classification: Class II
This distractor system is identical to the one cleared in 510(k) Prematket Notification (K002083). This device is composed of the This distractor system is identical to the one cleared in 510(x) i rematics (2017) 1777 177
same Lastosorb® end plates and fixation screws, and stainless steel drive screws a the added indication of mandibular distraction.
The Mandibular Distractor is the same as our previously cleared Alveolar Ridge Resorbile Distrector (K.O.203) with is and implantable device used to increase the heigh of the maxilla or replembly of the Alvola, probed stainless steel flexible implantable device used of two resorbable plates and a stainless steel drive for multiple tool deficiences. Sevel device is composed of two resorbable plates for single tooth use and large plates for multiple tooth deficiences. Several lengths of drive screw can be selected to achieve up to 25 mm of distraction.
The Mandibular Distractor can incorporate either of the two Alveolar Ridge resorbable devices dealed the two The Mandioular Distributing with no design changes. In addition, a third device is included that is is checked to the two mandrular or ramis lengthemig with to resign climber of the stores on tourses on the street placement. Each device estable Alveolar Ridge tesorbable plates and a suainess steel drive screw with permanedly and one of any area the street water st is composed of two resorbation plates and a samess storal be used in patents under two years of agence in a formation of the Devices would be positioned internally with drive screws external actived on external actives side of the estancement Devices would be completed prior to device placement. Lactoson plates would be affixed to staring staring the colones to mandle would be coupleted problems the dive serew using the attached shaft extension, causing the plates to Lactosoft screws. Distraction and consolidation, the drive shaft is detached from the plates and removed while the plates and screws remain internal and are resorbed.
Intended Use: The Lorenz Resorbable Distraction System includes devices intended for use in bone status may a move Intended Use: The Lorenz Resorband Distactor oystean moneos defects or post-tamator defects require gradual hone distraction. The Lorection of oral (alstaction System also includes devices intended for assistences intended bene distancion elongation (lengthening) when correction of maddbular defect require crating in construction in patients two (2) years old or younger. The mid-face distractor is intended primarily for LeFort III osteotomies.
Bone Plates: Lactosorb® (resorbable copolymer) – a polyesterderivative of lactic and glycolic acids Matcrials
Bone Screws: Lactosorb®
Drive Screw: Stainless steel
Shaft Extension: Titanium, Stainless Steel
Lactosoth® is made of 82% L-Lactidel 8% Clycolide oopolymer that degrades by hydrolysis into I-I.acction in the made of These hydrolytic products are then further department dioxide and water via the cellular Trebs cycle. Lactosoft & Moscophy of been provided by 510(k) notifications for use in boon plates (K992355, K992158, K971870, K960988, K955729) and bone screws (K981666, K960988) for cranial and maxillofacial use.
POSSIBLE ADVERSE EFFECTS AND COMPLICATIONS POSSIBLE ADVERSE EFFECTS AND COMPLICATIONS 25, 177525251
- Poor bone formation, osteoporosis, osteonyelitis, inhibited revascularization, or infection can cause 1. loosening, migration, bending, cracking or fracture of the device.
- Nonunion or delayed union may lead to breakage of the implant. 2.
- Bending, loosening, stripping the threads or fracture of the implant. 3.
- While rare, implantation of foreign materials can result in an inflammatory response or allergic reaction. র্ব .
- If metal pers of the device remain implanted, decrease in bone density due to stress shielding. ప్
1
- Pain, discomfort, abnormal sensation, or palpability due to the presence of the device. 6.
- Nerve damage due to surgical trauma. 7.
- Necrosis of bone. 8.
- Necrosis of bone.
Biomechanical complications after distraction due to positioning of the device. 9. -
- Tension of the soft tissue depending on the specificant and quality of the soft tissues and therefore interior and / or atrophy.
-
- Inadequate healing.
-
- Other conditions brought on by the surgical procedure including skin irritation and infection.
-
- Soft tissue adherence to device during activation.
Apart from these adverse effects there are always possible complications of any surgical procedure such as, but not limited (0, infection, nerve damage, and pain which may not be related to the implant.
Substantial Equivalence
Distraction Systems Lorenz Resorbable Distractor System (K002083) Lorenz Distraction System (K992952)
Resorbable Fixation Screws and Plates Lactosorb® Trauma Plating System (K971870) Lactosorb® Trauma Plating System (K955729) 2.5 MM Lactosorb® Screws (K981666) Lactosorb® Panels (K974309)
RELATED ARTICLES:
- Burstein MD, Fernando D., Williams MD, Joseph K., Hudgins MD, Roger, Graham MD, Leroy, Teague MD, Gerald, 1. Dustilli MD, Folland D., Williams No, Joseph Ingle-Stage Craniofacial Distraction Using Resorbable Devices. The Iournal of Craniofacial Surgery Vol. 13 No. 6 November 2002 pp. 776-782.
- Tournal of Cramonation Outgory versis in Maxillofacial Surgery using Internal Devices: Review of Five Cases. 2. Journal of Oral Maxillofacial Surgery 54:45, 1996.
- Tourill of Oth Maximolacal Surgery 34.15, 1795.
Chia M, Toth BA, LeFort III Advancement with Gradual Distraction Using Internal Devices. Plastic and Reconstructive 3. Surgery 100: 819, 1997 - Surgary 100: 01-7, 2017 র্ব . Plastic and Reconstructive Surgery 100: 831, 1997.
- Toth BA, Kim JW, Chin M, Celars M. Distraction Osteogenesis and its Application to the Midface and Bony Orbit in న్న Craniosynostosis Syndromes. Journal of Craniofacial Surgery 9:2, 100-112, 1997.
- Eppley, Barry L., Sandove, A Michael, A Companson of Resorbable and Metallic Fixation in Healing of Calvarial Bone 6. Grafts, Plastic and Reconstructive Surgery, August 1995.
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Image /page/2/Picture/0 description: The image shows the logo for W. Lorenz Surgical. The text "W. LORENZ" is in large, bold, black letters, with a line underneath. Below the line, the word "SURGICAL" is written in smaller, black letters.
01-50-1073 Draft 1520 Tradeport Drive Jacksonville, Florida 32218-2480 904-741-4400 O FAX 904-741-4500
Internal Distraction Devices ATTENTION OPERATING SURGEON
WARNINGS AND PRECAUTIONS FOR USE OF RESORBABLE MID-FACE, ALVEOLAR RIDGE, MANDIBULAR DISTRACTORS ALL INSTRUCTIONS MUST BE READ CAREFULLY PRIOR TO CLINICAL USE
DESCRIPTION
Walter Lorenz Surgical, Inc. manufactures and distributes distraction devices for use in bone stabilization and elongation (lengthening) when correction of oral, cranial, mandibular and maxillofacial deficiencies or post traumatic defects require gradual Each implantable distraction device has a hone distraction. titanium alloy drive screw mechanism and LactoSorb® resorbable connection plates, which are implanted by fixation with LactoSorb® bone screws.
Each device is made from one of the following matcrial(s): LactoSorb®, Titanium 6Al 4V Alloy, ASTM F-136, Stainless Steel, ASTM F-138
LactoSorb® is a resorbable copolymer, a polyester derivative of lactic and glycolic acids. Polylactic/polyglycolic acid copolymer degrades and resorbs IN VIVO by hydrolysis into lactic and glycolic acids that are then metabolized by the body.
INDICATIONS
- Correction of congenital or developed deficiencies of the oral 1. (alveolar ridge), cranial, and maxillofacial bone.
- Correction of congenital or developed deficiencies of the 2. mandibular bone in patients 2 years old or younger.
- Post-traumatic defects of the oral (alveolar ridge), cranial, 3. and maxillofacial skeleton.
- Post traumatic defects of the mandibular skeleton in patients 4. 2 years old or younger.
- Correction of midface deformities 5.
- LeFort III correction of deformity. 6
- Mandibular distraction ostcogenesis in patients 2 years old or 7. vounger.
CONTRAINDICATIONS
- Active infection. 1.
- Foreign body sensitivity. Where material sensitivity is 2. suspected, testing is to be completed prior to implantation.
- Patients with limited blood supply insufficient quantity or 3. quality of bone, or latent infection.
-
- Patients, or parents/guardians of patients are unwilling or incapable of following postoperative care instructions.
- Patients with bleeding disorders or poor wound healing. 5.
- Patients with metabolic disorders. 6.
WARNINGS
Distraction devices aid the surgeon in the defined step by step clongation of bone in the oral, cranial, mandibular, and maxillofacial skeleton. Correct handling, connection and placement of these implants are extremely important. The surgeon is to be thoroughly familiar with the implant, the specific method of application, as well as the local biomechanical situation of each patient. The surgeon must be thoroughly knowledgeable with the components, instruments and surgical procedure. Incomplete osteotomy or premature osteosynthesis may cause the device to bend, break, or the distraction screw to strip resulting in device malfunction or failure. The surgeon must plan proper placement mailmission of the device for each patient prior to implantation. Correct positioning of the device reduces the risk of device loosening from bone or possible biomechanical complications after distraction is complete. In Mandibular distraction, airway integrity should be closely monitored due to patient population. In all cases, sound surgical practice is to be followed.
- Improper selection, placement, positioning, and fixation of 1. the devices can cause a subsequent undesirable result. The surgeon is to be familiar with the devices, the method of application, and the surgical procedure prior to performing surgery.
- Correct handling of the implant is extremely important. 2. Implants should be modified only when necessary. Modifications or excessive contouring of implants may cause damage to the device. Notches, dents, and scratches resulting from the modifications can contribute to breakage.
- Intraoperative fracture of screws or plates can occur if 3. excessive force is applied while seating bone screws.
- The resorbable plates can be heated and shaped as desired 4. up to and including three times using a LactoSorb® Heat Pack or a hot sterile saline/water bath. LactoSorb® exposure to the bath should be a maximum of 15 seconds per bath with the temperature not exceeding 85℃. LactoSorb® plates cannot be applied, removed, and reapplied after fixation with screws is completed.
- Implants may be removed after the fracture has healed. 5. Implants can loosen, fracture, corrode or cause pain. If an implant remains implanted after complete healing, the implant may cause stress shielding, which may increase the risk of refracture.
- Adequately instruct the patient, parents or guardians. The 6. cooperation and willingness of the patient, parents or guardians over the course of the complete treatment is extremely important. Postoperative care and the patient's, parents' or guardians' ability and willingness to follow instructions are important aspects of successful distraction and healing. A daily distraction plan should be worked out with the patient and / or guardian. The patient, parent or guardian is to be warned that failure to follow postoperative instructions can cause failure of the device or the treatment. If loosening or metal fatigue occurs before distraction is complete, revision surgery may be necessary to replace or remove the device.
- For mandibular distraction, the patient should be limited to a 7. soft diet throughout distraction and consolidation phases. Soft diet should consist of food no barder than cooked pasta.
- The patient's parent or guardian is to be made fully aware 8. and warned that the device can break, bend or be damaged as a result of stress, activity, and load bearing. The patient is to be made aware and warned of general surgical risks, complications, and all possible adverse effects.
- The surgeon should weigh the risks versus benefits when ರ. deciding to remove the implant. Generally, LactoSorb devices require only the removal of titanium alloy components (plates and screws are not removed). Adequate postoperative management should follow implant removal.
- Discard and DO NOT USE previously opened or damaged 10. devices. Use only devices that are packaged in unopened or undamaged containers.
- DO NOT USE if there is loss of sterility of the device, or if 11. the expiration date has passed.
PRECAUTIONS
Do not reuse implants. While an implant may appear undamaged, previous stress may have created imperfections that would reduce
3
the service life of the implant. Do not treat patients with implants that have been even momentarily placed in a different patient.
Surgical instruments must be used only for the device systems for which they are designed. Use of other manufacturer instruments can involve incalculable risks for the implant and instrument, thereby potentially endangering the patient, user, or third party. Intra-operative fracture or breaking of instruments has been mitra-operative "hat instruments are subject to wear with normal usage. Instruments, which have experienced extensive use or excessive force, are susceptible to fracture. Walter Lorenz recommends that all instruments be regularly inspected for wear and disfigurement.
Bone Plates:
Distraction devices have resorbable bone plates for implanting the Distraction devices may require contouring to the surface of the bone by heat contouring using a LactoSorb® Heat Pack or a hot sterile saline/water bath. LactoSorb® exposure to the bath should be a maximum of 15 seconds per bath with the temperature not Do not attempt to bend resorbable plates with exceeding 85°C. plate benders.
- Care must be taken to achieve the appropriate contour with as few bends as possible.
- Sharp angles and small bending radii must be avoided to reduce the risk of the device breaking.
- Do not over-trim the plates. Trimming the connection plates may cause premature weakening and failure of the plates.
Bone Screws:
- The screwdriver which has been designed for a particular system of screws must always be used to be sure that proper screwdriver/screw head connection is achieved.
- Incorrect alignment of fit of the screwdriver to the screw head may increase the risk of damage to the implant or screwdriver.
- Excessive torque can cause the screw or plate to fracture. -
- A sufficient number of screws should be used in each plate to r assure solid fixation through the distraction/consolidation period. Implanting a plate using an insufficient quantity of screws can lead to premature failure of the procedure.
- LactoSorb® bone screws should never be heated. -
Drive Shaft Extensions sad Connections
- Flexible shafts may be weakened or break as a result of excessive force.
- The connection sleeve must be locked down and remain locked during the entire distraction period.
Twist Drills:
Twist drills are labeled for single procedure use only.
- When using twist drills, appropriate cooling is necessary to minimize thermal damage to bone tissue. It should be combined with low speed drilling to prevent the risk of bone demineralization and possible loosening of the bone screw.
- The manufacturers instructions for the hand piece used with ﻌ the twist drill must be followed. The manufacturer of the handpiece may recommend proper speeds to avoid failures such as breakage of the twist drill.
- Excessive force may cause unusual stress conditions and . result in breakage or fracture of the device.
- Breakage of twist drills may result in injury to the patient, the ﮯ user, or third party.
- If a twist drill fails during use, the drill guides aid in the ﮯ protection of the patient, user or third party.
POSSIBLE ADVERSE EFFECTS AND COMPLICATIONS
- Poor bone formation, osteoporosis, osteolysis, ostcomyclitis, 1. inhibited revascularization, or infection can cause loosening, migration, bending, cracking or fracture of the device.
- Nonunion or delayed union may lead to breakage 2. implant.
- Bending, loosening, stripping the threads or fracture of the 3. implant.
- While rare, implantation of foreign materials can result in an 4. inflammatory response or allergic reaction.
- If metal parts of the device remain implanted, decrease in 5. bone density due to stress shielding.
- Pain, discomfort, abnormal sensation, or palpability due to 6. the presence of the device.
- Nerve damage due to surgical trauma. 7
- Necrosis of bone. દર્શને સંદર્ભ દર્શના પાકની ખેત
- Biomechanical complications after distraction due to 9. positioning of the device.
- Tension of the soft tissue depending on the speed of 10. distraction and quality of the soft tissues and therefore imtation and / or atrophy.
- Inadequate healing. 11.
- Other conditions brought on by the surgical procedure 12. including skin irritation and infection.
- Soft tissue adherence to device during activation. 13.
Apart from these adverse effects there are always possible complications of any surgical procedure such as, but not limited to, infection, nerve damage, and pain which may not be related to the implant.
STERILITY
Distraction devices are supplied sterile by exposure to ethylene oxide (ETO) gas. DO NOT RESTERILIZE. DO NOT USE after expiration date bas passed.
STORE AT OR BELOW ROOM TEMPERATURE. DO NOT EXPOSE PRODUCT TO TEMPERATURES GREATER THAN 120° F OR 49° C.
Caution: Federal Jaw (USA) restricts this device to sale by or on the order of a physician.
Operating Surgeons and all personnel involved with handling these products are responsible for attaining appropriate education and training within the scope of the activities which they are involved in the handling and use of this product.
Authorized Representative in EC:
Biomet UK, Ltd. Waterton Industrial Estates, Bridgend, South Wales CF31 3XA, U.K. Phone: (+44) 1656 655221 (+44) 1656 645454 Fax:
European Sales Headquarters: W. Lorenz Surgical Europe Toermalijning 600 3316 LC Dordrecht Netherlands Phone:. (+31) 78 629 29 10 (+31) 78 629 29 12 Fax
Manufacturer: Biomet Inc. 56 East Bell Drive PO Box 587 Warsaw, Indiana 46581 USA
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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized symbol that resembles an abstract representation of a human form or a caduceus. The image is in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 4 2004
Ms. Kim Reed Senior Regulatory Specialist Walter Lorenz Surgical, Incorporated 1520 Tradeport Drive Jacksonville, Florida 32218
Re: K030425
Trade/Device Name: Lorenz Resorbable Distraction System Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Codc: JEY Dated: March 4, 2004 Received: March 5, 2004
Dear Ms. Reed:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed prodicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.
5
Page 2 - Ms. Reed
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements not that I L any Federal statutes and regulations administered by other Federal agencies. or mo ret or anyly with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and insine (s as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mo reter notification. The FDA finding of substantial equivalence of your device to a premiance results in a classification for your device and the your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), nlease contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincercly yours,
Clus
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
STATEMENT OF INDICATIONS FOR USE
510(k) Number K030425
Device Name: Lorenz Resorbable Distraction System Indications for Use:
The Lorenz Resorbable Distraction System includes devices intended for use in bone stabilization and elongation (lengtheming) I ho corection of oral (alveolar ridge), cranial, and maxillofacial deficiencies or post-traumatic defects require gradual bone with correction. The Lorenz Resorbable System also includes devices intended for use in bone stabilization and elongation (lengthening) when correction of maddibular deficiencies or post-traumatic defects require gradual bone distraction in patients two (2) years old or younger. The mid-face distractor is indicated primarily for LeFort III osteotomies.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDHR, Office of Device Evaluation (ODE)
OR
Prescription Use (Per 21 CFR 801.109
Over-the-Counter-Use (Optional Format 1-2-96)
Quls
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
310(k) Number: K030425