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

    BREMER HALO SYSTEM

    K Number: K864746 · Decision Dec 22, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    19
    Applicant Total
    1
    Review Days
    17

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    Basic Information

    Device Name
    BREMER HALO SYSTEM
    K Number
    K864746
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5960
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Bremer Orthopedics
    Date Received
    December 5, 1986
    Decision Date
    December 22, 1986
    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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