BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    GELSKIN

    K Number: K791162 · Decision Sep 4, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    92
    Applicant Total
    10
    Review Days
    71

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    Basic Information

    Device Name
    GELSKIN
    K Number
    K791162
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5720
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Spenco Medical Corp.
    Date Received
    June 25, 1979
    Decision Date
    September 4, 1979
    Product Code
    ILO
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ILO Pack, Hot Or Cold, Water Circulating

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    Other Clearances by Spenco Medical Corp.

    K Number Device Name
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    K911550 2ND SKIN MOIST BURN PADS WITH ALOE
    K910927 SPENCIO SKIN GUARD KIT
    K896533 SPENCO BREAST FORMS
    K894898 2ND SKIN NON-STICK MOIST BURN PADS
    K820906 SPENCO CRYOPRESS
    K811184 SPENCO DERMAL PADS
    K791726 HYDROGEL-PREP