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

    GAUZE & LAB SPONGES STERILE & NON

    K Number: K842572 · Decision Aug 15, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    211
    Registration Numbers
    211
    Same Product Code
    110
    Applicant Total
    21
    Review Days
    43

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    Basic Information

    Device Name
    GAUZE & LAB SPONGES STERILE & NON
    K Number
    K842572
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4450
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Ulti-Med Intl., Inc.
    Date Received
    July 3, 1984
    Decision Date
    August 15, 1984
    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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