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

    MCNEALY-GLASSMAN VISCERA RETAINER #3202/3204/3206

    K Number: K870809 · Decision Mar 19, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    4
    Applicant Total
    6
    Review Days
    16

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    Basic Information

    Device Name
    MCNEALY-GLASSMAN VISCERA RETAINER #3202/3204/3206
    K Number
    K870809
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Adept-Med Intl., Inc.
    Date Received
    March 3, 1987
    Decision Date
    March 19, 1987
    Product Code
    GCZ
    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
    GCZ Retainer, Surgical

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