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510(k) Data Aggregation

    K Number
    K972081
    Device Name
    SUPERSKIN
    Date Cleared
    1997-12-17

    (197 days)

    Product Code
    Regulation Number
    880.5090
    Why did this record match?
    Product Code :

    NEC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SuperSkin® helps to protect skin exposed to irritation from moisture such as sweat, urine, and digestive juices. SuperSkin® can also be used on unbroken skin surfaces that are exposed to friction and shear. Do not apply over broken skin.
    Device Description
    SuperSkin® is a topically-applied skin protectant for use on unbroken skin. The patient applies between 2-4 drops of SuperSkin® to the intact skin. The liquid polymerizes to form a thin, flexible coating.
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