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

    BRACE, TENNIS ELBOW

    K Number: K780053 · Decision Jan 17, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    503
    Registration Numbers
    503
    Same Product Code
    51
    Applicant Total
    632
    Review Days
    8

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    Basic Information

    Device Name
    BRACE, TENNIS ELBOW
    K Number
    K780053
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3475
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    January 9, 1978
    Decision Date
    January 17, 1978
    Product Code
    IQI
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IQI Orthosis, Limb Brace

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