BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SUPERSKIN

    K Number: K972081 · Decision Dec 17, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    142
    Registration Numbers
    142
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    197

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    Basic Information

    Device Name
    SUPERSKIN
    K Number
    K972081
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5090
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medlogic Global Corp.
    Date Received
    June 3, 1997
    Decision Date
    December 17, 1997
    Product Code
    NEC
    Advisory Committee
    General Hospital
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NEC Bandage, Liquid, Skin Protectant

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NEC), ordered by most recent decision date.

    APLICARE SKIN PROTECTANT PREP PAD

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    FDA Class 1 ·General Hospital

    APLICARE SKIN PROTECTANT SWABSTICK

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    Other Clearances by Medlogic Global Corp.

    K Number Device Name
    K993556 LIQUIBAND DENTAL