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

    K AND D HOME TRACT

    K Number: K872121 · Decision Aug 12, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    223
    Registration Numbers
    223
    Same Product Code
    37
    Applicant Total
    1
    Review Days
    77

    Basic Information

    Device Name
    K AND D HOME TRACT
    K Number
    K872121
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.5850
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    JOSEPH A. KOTT, M.D.
    Date Received
    May 27, 1987
    Decision Date
    August 12, 1987
    Product Code
    HST
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HST Apparatus, Traction, Non-Powered

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