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

    VISECERA RETAINER

    K Number: K802806 · Decision Jan 23, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    4
    Applicant Total
    6
    Review Days
    77

    Basic Information

    Device Name
    VISECERA RETAINER
    K Number
    K802806
    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
    November 7, 1980
    Decision Date
    January 23, 1981
    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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