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510(k) Data Aggregation

    K Number
    K232758
    Device Name
    Comatryx OTC
    Manufacturer
    Strukmyer Medical, LLC.
    Date Cleared
    2023-12-01

    (84 days)

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

    Strukmyer Medical, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for the management of minor scrapes, minor bruises, minor abrasions, minor lacerations, and minor burns.
    Device Description
    CoMatryx OTC Collagen Wound Dressing is a native bovine Type I Collagen which, when applied to a wound surface in powder or pad form, absorbs wound fluid and maintains a moist wound environment. The CoMatryx OTC powder and pads are provided sterile in the following configurations: - . 1 gram powder in 1 pouch - 2"x2," 3"x4," and 8"x12" pad in pouch
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