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

    RESOLVE OPEN BACK HALO RINGS

    K Number: K051918 · Decision Aug 17, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    19
    Applicant Total
    9
    Review Days
    33

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    Basic Information

    Device Name
    RESOLVE OPEN BACK HALO RINGS
    K Number
    K051918
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.5960
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jerome Medical
    Date Received
    July 15, 2005
    Decision Date
    August 17, 2005
    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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