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

    GAUZE SPONGE

    K Number: K853742 · Decision Oct 8, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    211
    Registration Numbers
    211
    Same Product Code
    110
    Applicant Total
    7
    Review Days
    32

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    Basic Information

    Device Name
    GAUZE SPONGE
    K Number
    K853742
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4450
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    South Mountain Medical
    Date Received
    September 6, 1985
    Decision Date
    October 8, 1985
    Product Code
    GDY
    Advisory Committee
    General, Plastic Surgery
    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
    GDY Gauze/Sponge, Internal, X-Ray Detectable

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