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

    TOMAC STERILE DISP. LAP SPONGE

    K Number: K812554 · Decision Sep 24, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    211
    Registration Numbers
    211
    Same Product Code
    110
    Applicant Total
    19
    Review Days
    16

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    Basic Information

    Device Name
    TOMAC STERILE DISP. LAP SPONGE
    K Number
    K812554
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4450
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    American Convertors Div., American Pharmaseal
    Date Received
    September 8, 1981
    Decision Date
    September 24, 1981
    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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    Other Clearances by American Convertors Div., American Pharmaseal

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    K813078 CONTURA DISPOS. SURG. FACE MASK
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