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510(k) Data Aggregation
K Number
K141747Device Name
RHINOGUARD
Manufacturer
DAVIS MEDICAL
Date Cleared
2015-04-20
(294 days)
Product Code
BTR
Regulation Number
868.5730Why did this record match?
Applicant Name (Manufacturer) :
**DAVIS **MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Rhinoguard is a nasal endotracheal tube introducer/dilator designed to allow the passage of a nasal endotracheal tube from the nares to the oropharynx.
The device can be used with cuffed and non-cuffed nasal endotracheal tubes.
Device Description
The Rhinoguard is a nasal endotracheal tube introducer/dilator designed to ease the passage of a nasal endotracheal tube from the nares to the oropharynx. The Rhinoguard device is constructed primarily of polyvinylchloride and consists of a tube with a hollow proximal end, a tapered cylindrical body and a closed, rounded distal end. The device has markings to indicate the approximate mating location for corresponding sizes of nasal endotracheal tubes. The device is provided in a small and large size. The small Rhinoguard is intended to mate with 3.0 to 4.5 mm nasal endotracheal tubes and the large Rhinoguard is intended to mate with 5.0 to 8.0 mm nasal endotracheal tubes. The device can be used with cuffed and non-cuffed nasal endotracheal tubes. Prior to using the device, the desired size of the nasal endotracheal tube must be selected and then matched to corresponding Rhinoguard size (large or small). The device is then cut just above the indices (marks) corresponding to the selected endotracheal tube size and connected with the endotracheal tube. Once mated, the distal end of the device is introduced into the naris of choice and gently pushed forward into the oropharynx. Lastly, the distal end of Rhinoguard is grasped and removed from the mouth with the aid of a laryngoscope and McGill forceps.
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K Number
K121287Device Name
HT-WEDGE
Manufacturer
D.T. DAVIS ENTERPRISES LTD. T/A HOVERTECH INT'L
Date Cleared
2012-10-03
(156 days)
Product Code
FNG
Regulation Number
880.5500Why did this record match?
Applicant Name (Manufacturer) :
**DAVIS **ENTERPRISES LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The purpose of the HT-Wedge is to pneumatically lift and position the head and chest of a patient who is lying in the supine position without manual lifting.
Device Description
The HT-Wedge is an inflatable wedge with square headrest and two intake appendages, one for the head and one for the chest. An inflation/deflation valve is found in each appendage. There is also a tongue attached to the wedge that lies under the patient's buttocks. The inflatable portion of the product is 22" wide and 31 1/4" long. There are four attachment straps, two located on each side of the wedge in order for it to be secured to the OR table. The tongue adds an additional 20" in length. The wedge is constructed of polyurethane coated nylon with 2 one-way, inflation/deflation valves.
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K Number
K102236Device Name
HOVERTRANS TRANSFORMER WITH POWER DRIVE MODEL HTT-650P
Manufacturer
D.T. DAVIS ENTERPRISES LTD. T/A HOVERTECH INT'L
Date Cleared
2010-11-18
(101 days)
Product Code
INK
Regulation Number
890.3690Why did this record match?
Applicant Name (Manufacturer) :
**DAVIS **ENTERPRISES LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is a motorized device intended for medical purposes to assist in transfer of a patient to and from beds, chairs, treatment facilities, wheelchairs or transport vehicles.
Device Description
The HoverTech International Transformer is a battery powered patient transport device with a motorized drive to aid the caregiver in maneuvering the device while transporting patients within care facilities. Its intended function and use is to transport patients to various areas within the patient care facility and may contain supports for fluid infusion equipment. It can also be used to support the patient in a seated or supine position during examinations, physical therapy and other clinical activities within the patient care facility. The adjustability of the Transformer allows for better patient access by caregivers and also provides for enhanced patient comfort.
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K Number
K041503Device Name
HOVERJACK AIR PATIENT LIFT DEVICE
Manufacturer
D.T. DAVIS ENTERPRISES LTD.
Date Cleared
2004-08-12
(66 days)
Product Code
FNG
Regulation Number
880.5500Why did this record match?
Applicant Name (Manufacturer) :
**DAVIS **ENTERPRISES LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HoverJack™ lifts a patient in a supine position, from the floor to the approximate height of a bed for a subsequent lateral patient transfer.
Device Description
The HoverJack™ is made of four connected nylon air chambers, each measuring 32" x 70". When inflated, each chamber is 7" high. Each chamber has a dump valve for safety purposes. Each of these chambers has an air entry valve through which an external air supply is used to inflate the chamber against the floor is to be inflated first, then the other three chambers are inflated, in an upward succession, until the device is fully inflated. When fully inflated, the HoverJack™ feels hard and substantially supports the patient atop it, also providing a surface upon which emergency patient procedures can be performed, if necessary. Also in an emergency, dump valves are available to use for quick deflation. The HoverJack™ is constructed using 200 denier Nylon Oxford. Seams are RF welded (heat-sealed) to limit infection control issues. The bottom of the HoverJack™ has strips of a non-skid material attached for safety purposes. Fill-valves are self-sealing AND have caps that also screw on for additional closure. The HoverJack™ has two patient safety straps to buckle over the patient. The HoverJack™ does require the use of the Air Supply that is available as a separate unit. The Air Supply is CSA approved, meeting UL Standard #544. This Air Supply is also used to inflate other equipment such as the HoverMatt® which is an optional accessory to the HoverJack™.
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K Number
K024252Device Name
MATCH MASTER LOW FUSION PORCELAIN
Manufacturer
DAVIS SCHOTTLANDER & DAVIS, LTD.
Date Cleared
2004-01-22
(395 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
**DAVIS **SCHOTTLANDER & DAVIS, LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Match Master low fusing porcelain is to be used in conjunction with metal or pressable ceramic framework in the construction of crowns and/or bridgework.
Device Description
Not Found
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K Number
K024250Device Name
MATCH PRESS PRESSABLE CERAMIC
Manufacturer
DAVIS SCHOTTLANDER & DAVIS, LTD.
Date Cleared
2003-08-25
(245 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
**DAVIS **SCHOTTLANDER & DAVIS, LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Match Press pressable ceramic is to be used in the construction of crown substructures to be veneered with conventional porcelain. For use only by or on the order of a dental professional such as DDS or DMD. Not for use by general public or OTC.
Device Description
Not Found
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K Number
K001463Device Name
SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156
Manufacturer
DAVIS SCHOTTLANDER & DAVIS, LTD.
Date Cleared
2000-06-16
(37 days)
Product Code
EBI
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
**DAVIS **SCHOTTLANDER & DAVIS, LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K993717Device Name
ENIGMA HI-BASE DENTURE BASE MATERIAL
Manufacturer
DAVIS SCHOTTLANDER & DAVIS, LTD.
Date Cleared
1999-12-22
(49 days)
Product Code
EBI
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
**DAVIS **SCHOTTLANDER & DAVIS, LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ENIGMA denture base is to be used in conjunction with denture teeth in the construction of full and partial dentures. For use only by or on the order of a dental professional such as DDS or DMD. Not for use by general public or OTC.
Device Description
Schottlander ENIGMA HI-BASE Denture base material
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K Number
K982853Device Name
SILK SUTURE
Manufacturer
DAVIS & GECK, INC.
Date Cleared
1999-04-30
(260 days)
Product Code
GAP
Regulation Number
878.5030Why did this record match?
Applicant Name (Manufacturer) :
**DAVIS **& GECK, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Silk sutures are indicated for use as nonabsorbable sutures in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neural tissue.
Device Description
Silk Non-Absorbable Surgical Sutures are composed of the organic protein fibroin which is derived from the domesticated species Bombyx mori (B.mori) of the family Bombycidae. Silk sutures are braided or twisted and available in white or dyed (black or blue). Braided sutures (except for size 8/0) are coated with silicone. Silk sutures are also available in various lengths, diameters and quantities with or without surgical needles. SILK sutures are not absorbed, progressive degradation of the proteinaceous silk fiber in-vivo may result in gradual loss of all the suture's tensile strength over time. The proposed Silk suture needle will be manufactured using an automated end stiffening process of applying the medical grade adhesive to a portion of the silk strand which is then cured and cut to length.
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K Number
K984134Device Name
NATURA DENTURE TEETH
Manufacturer
DAVIS SCHOTTLANDER & DAVIS, LTD.
Date Cleared
1999-02-12
(86 days)
Product Code
ELM
Regulation Number
872.3590Why did this record match?
Applicant Name (Manufacturer) :
**DAVIS **SCHOTTLANDER & DAVIS, LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NATURA teeth are to be used in conjunction with denture base resin for the construction of full and partial dentures. For use only by or on the order of a dental professional such as DDS or DMD. Not for use by general public or OTC.
Device Description
Not Found
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