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510(k) Data Aggregation

    K Number
    K980563
    Device Name
    SKAR-KARE SHEET
    Manufacturer
    LIFE MEDICAL SCIENCES, INC.
    Date Cleared
    1998-05-20

    (96 days)

    Product Code
    MDA
    Regulation Number
    878.4025
    Why did this record match?
    Applicant Name (Manufacturer) :

    LIFE MEDICAL SCIENCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SKAR-KARE™-SHEET is intended for use in the topical management of hypertrophic and keloid scars. Do not use on open wounds.
    Device Description
    SKAR-KARE™-SHEET is a soft, durable and washable elastic device for topical patient use over intact skin. It is not sterile. It is composed of a standard silicone sheeting (inert) in a flexible-link, ionic, micro-patterned appearance.
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