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510(k) Data Aggregation

    K Number
    K112580
    Device Name
    COLLAGEN WOUND DRESSING
    Manufacturer
    DALIM TISSEN CO., LTD.
    Date Cleared
    2012-06-01

    (269 days)

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

    DALIM TISSEN CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Collagen Wound Dressing is intended use for management of partial and full-thickness wounds including: pressure ulcers, venous ulcers, diabetic ulcers, tunneled / undermined wounds, surgical wound (donor sites / grafts, post-moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), draining wounds.
    Device Description
    Collagen Wound Dressing (Absorbable Collagen Membrane) is a sterile, pliable porous and dense wound dressing made of highly purified collagen derived from porcine skin. It is crosslinked using 1-ethyl-3-(3-dimethyl aminopropyl) carbodiimide (EDC) for the resistance to enzymatic degradation. Collagen Wound Dressing is completely absorbable and highly biocompatible. Collagen Wound Dressing is composed of porous sponge layer for the wound surface and dense film layer for protecting wound from outside.
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