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510(k) Data Aggregation

    K Number
    K063805
    Device Name
    SILCRYST SILVER ANTIMICROBIAL WOUND CREAM, MODEL A-00901
    Date Cleared
    2007-07-13

    (203 days)

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

    NUCRYST PHARMACEUTICALS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Silcryst® Silver Antimicrobial Wound Cream is intended for external management of partial and full-thickness wounds including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, abrasions, lacerations, cuts, donor sites and surgical wounds.
    Device Description
    Silcryst® Silver Antimicrobial Wound Cream is a non-sterile, semi-viscous emulsion intended for topical application for external wound management. It aids the body by providing a moist wound environment optimal for healing. The cream also serves as a broad spectrum anti-microbial barrier. It is presented as a prescription product.
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