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

    EXTERNAL BREAST PROSTHESIS

    K Number: K813416 · Decision Jan 18, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    16
    Applicant Total
    9
    Review Days
    42

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    Basic Information

    Device Name
    EXTERNAL BREAST PROSTHESIS
    K Number
    K813416
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.3800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Surgical Appliance Industries, Inc.
    Date Received
    December 7, 1981
    Decision Date
    January 18, 1982
    Product Code
    GBI
    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
    GBI Material, External Aesthetic Restoration, Used With Adhesive

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