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510(k) Data Aggregation

    K Number
    K141747
    Device Name
    RHINOGUARD
    Manufacturer
    DAVIS MEDICAL
    Date Cleared
    2015-04-20

    (294 days)

    Product Code
    BTR
    Regulation Number
    868.5730
    Why 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
    K121287
    Device 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
    880.5500
    Why 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
    K102236
    Device 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
    890.3690
    Why 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
    K041503
    Device Name
    HOVERJACK AIR PATIENT LIFT DEVICE
    Manufacturer
    D.T. DAVIS ENTERPRISES LTD.
    Date Cleared
    2004-08-12

    (66 days)

    Product Code
    FNG
    Regulation Number
    880.5500
    Why 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
    K024252
    Device Name
    MATCH MASTER LOW FUSION PORCELAIN
    Manufacturer
    DAVIS SCHOTTLANDER & DAVIS, LTD.
    Date Cleared
    2004-01-22

    (395 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why 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
    K024250
    Device Name
    MATCH PRESS PRESSABLE CERAMIC
    Manufacturer
    DAVIS SCHOTTLANDER & DAVIS, LTD.
    Date Cleared
    2003-08-25

    (245 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why 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
    K001463
    Device Name
    SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156
    Manufacturer
    DAVIS SCHOTTLANDER & DAVIS, LTD.
    Date Cleared
    2000-06-16

    (37 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Why 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
    K993717
    Device Name
    ENIGMA HI-BASE DENTURE BASE MATERIAL
    Manufacturer
    DAVIS SCHOTTLANDER & DAVIS, LTD.
    Date Cleared
    1999-12-22

    (49 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Why 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
    K982853
    Device Name
    SILK SUTURE
    Manufacturer
    DAVIS & GECK, INC.
    Date Cleared
    1999-04-30

    (260 days)

    Product Code
    GAP
    Regulation Number
    878.5030
    Why 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
    K984134
    Device Name
    NATURA DENTURE TEETH
    Manufacturer
    DAVIS SCHOTTLANDER & DAVIS, LTD.
    Date Cleared
    1999-02-12

    (86 days)

    Product Code
    ELM
    Regulation Number
    872.3590
    Why 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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