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510(k) Data Aggregation

    K Number
    K091863
    Device Name
    AWBAT-S PLUS, AWBAT-D PLUS, AWBAT-M PLUS
    Manufacturer
    AUBREY, INC.
    Date Cleared
    2010-01-21

    (212 days)

    Product Code
    FRO, KGN
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    AUBREY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AWBAT-S Plus: is intended for clean Superficial burn wounds. AWBAT-D Plus: are intended for Donor sites after hemostasis has been established. AWBAT-M Plus: are intended to be used as a protective covering for Meshed autografts.
    Device Description
    A Temporary Wound Dressing for coverage of Superficial burns, Donor sites and Meshed autografts until healing occurs. AWBAT Plus is composed of a single or multiple filesned knitted nylon fabric, bonded to a thin porous silicone membrane (enproximately 0.01 inch). The nylon side of these components is coated with a non-toxic mixture of porcine collagen. peptides, chondroitin-4-sulfate, chondroitin-6-sulfate, Immuno-10 (Aloe polysiaconarides), vitamin C, vitamin E, and polysorbate 20. AWBAT Plus is manufactured in 12"x12" sheets that are cut to sizes of 6"x6", 6"x12" and 12"x12" and ink stamped AWBAT-S Plus, AWBAT-D Plus, AWBAT-M Plus accordingly. AWBAT-S Plus has pores in the silicone membrane at 1/4" centers and the approximate area of an AWBAT-S Plus pore is 0.0036 square inch each. AWBAT-D Plus has pores in the silicone membrane at 1/4" centers and the approximate area of an AWBAT-D Plus pore is 0.0073 square inch each. AWBAT-M Plus has pores in the silicone membrane at 1/4" centers and the approximate area of an AWBAT-M Plus pore is 0.0070 square inch each.
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    K Number
    K082869
    Device Name
    AWBAT-S, AWBAT-D, AWBAT-M
    Manufacturer
    AUBREY, INC.
    Date Cleared
    2009-02-06

    (130 days)

    Product Code
    KGN
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    AUBREY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AWBAT-S is intended for clean Superfical burn wounds. AWBAT-D is intended for Donor sites after hemostasis has been established. AWBAT-M is to be used as protective covering for Meshed autografts.
    Device Description
    A Temporary Wound Dressing for coverage of Superficial burns, Donor sites and Meshed autografts until healing occurs. AWBAT is composed of a single or multiple filament knitted nylon fabric, bonded to a thin porous silicone membrane (approx 0.001 inch). The nylon side of these components is coated with a non-toxic mixture of porcine collagen peptides. AWBAT is manufactured in 12"x12" sheets that are cut to sizes of 3"x3", 6"x12" and 12"x12" and ink stamped "AWBAT-S," "AWBAT-D" or "AWBAT-M" accordingly. AWBAT-S has pores in the silicone membrane at 1/4" centers and the approximate area of an AWBAT-S pore is 0.0036 square inch each. AWBAT-D has pores in the silicone membrane at 1/4" centers and the approximate area of an AWBAT-D pore is 0.0073 square inch each. AWBAT-M has pores in the silicone membrane at 1/4" centers and the approximate area of an AWBAT-M pore is 0.0070 square inch each. AWBAT-S is composed of a 15/2 denier multiple filament nylon knitted fabric, bonded to a thin porous silicone membrane. The nylon side of these components is coated with a non-toxic mixture of porcine collagen peptides (xenogenic component). AWBAT-D has the same composition as AWBAT-S, except it is more porous to enable the clinician to evacuate a clot through the membrane into an outer sterile wrap. AWBAT-M has the same composition as AWBAT-D, except the 12/1 denier nylon fabric is monofilament (thinner & less adherent).
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