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510(k) Data Aggregation

    K Number
    K962439
    Device Name
    DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10)
    Manufacturer
    RICHARD HAMER ASSOC., INC.
    Date Cleared
    1996-09-03

    (71 days)

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

    RICHARD HAMER ASSOC., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For the local management of pressure ulcers, stasis ulcers, 1st and 2nd degree burns, and full and partial thickness wounds.
    Device Description
    The Dermaplex Hydrogel Wound Dressing consists of a 12-ply cotton gauze pad dressing impregnated with a clear, viscous hydrogel. The product is available in four sizes (2" x 2", 4" x 4", 4" x 8" and 6" x 10") and is supplied sterile in sealed aluminum/plastic laminate pouches.
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