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

    FRACTURE BRACING

    K Number: K780892 · Decision Jun 13, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    442
    Registration Numbers
    442
    Same Product Code
    14
    Applicant Total
    9
    Review Days
    13

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    Basic Information

    Device Name
    FRACTURE BRACING
    K Number
    K780892
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3475
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Hosmer Dorrance Corp.
    Date Received
    May 31, 1978
    Decision Date
    June 13, 1978
    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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