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

    BRACE C.T.

    K Number: K831310 · Decision May 16, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    442
    Registration Numbers
    442
    Same Product Code
    14
    Applicant Total
    2
    Review Days
    24

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    Basic Information

    Device Name
    BRACE C.T.
    K Number
    K831310
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3475
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Innovation Sports, Inc.
    Date Received
    April 22, 1983
    Decision Date
    May 16, 1983
    Product Code
    ITQ
    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
    ITQ Joint, Knee, External Brace

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