BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    HALO SUPPORT JACKET & ASSOC. HARDWARE

    K Number: K792586 · Decision Dec 31, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    19
    Applicant Total
    303
    Review Days
    14

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    Basic Information

    Device Name
    HALO SUPPORT JACKET & ASSOC. HARDWARE
    K Number
    K792586
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5960
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Depuy, Inc.
    Date Received
    December 17, 1979
    Decision Date
    December 31, 1979
    Product Code
    HAX
    Advisory Committee
    Neurology
    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
    HAX Tong, Skull For Traction

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