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    K Number
    K974354
    Device Name
    MEPIFORM ADHERENT SILICONE DRESSING FOR SCAR CARE
    Manufacturer
    SCA MOLNLYCKE
    Date Cleared
    1998-03-05

    (106 days)

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

    SCA MOLNLYCKE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Mepiform Adherent Silicone Dressing is intended for the management of both old and new hypertrophic and keloid scars. It can also be used as a prophylactic therapy on closed wounds which may prevent hypertrophic or keloid scarring.
    Device Description
    The Mepiform Adherent Silicone Dressing for Scar Care consists of a silicone coated nonwoven bonded to an adhesive thermoplastic polyurethene film. The silicone dressing is protected by a low density polyethylene release film. The Mepiform dressing is individually sealed in a medical grade paper pouches and packaged in cartons of five (5) pouches each. The Mepiform dressings are available in two sizes: 5 cm x 7.5 cm (2" x 3") and 10 cm x 18 cm (4" x 7").
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