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

    ADVANCE LAPAROTOMY SPONGE, LAP SPONGE

    K Number: K903358 · Decision Nov 29, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    211
    Registration Numbers
    211
    Same Product Code
    110
    Applicant Total
    32
    Review Days
    126

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    Basic Information

    Device Name
    ADVANCE LAPAROTOMY SPONGE, LAP SPONGE
    K Number
    K903358
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4450
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Advance Medical Designs, Inc.
    Date Received
    July 26, 1990
    Decision Date
    November 29, 1990
    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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