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510(k) Data Aggregation

    K Number
    K071354
    Device Name
    MEPILEX AG DRESSING
    Manufacturer
    MONLYCKE HEALTH CARE
    Date Cleared
    2007-07-13

    (59 days)

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

    MONLYCKE HEALTH CARE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Mepilex Ag Dressing is indicated for the management of low to moderately exuding wounds such as leg and foot ulcers, pressure ulcers and partial thickness burns. Silver sulphate present in the dressing helps reduce microbial colonization on the dressing.
    Device Description
    Mepilex Ag is an anti-microbial, absorbent soft silicone dressing consisting of a flexible, absorbent polvurethane foam pad with added silver and activated charcoal, which is coated with a silicone wound contact layer and a wrinkled water vapor permeable polyurethane film backing. The silicone layer is covered with a polyethylene release film.
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