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

    #CTO 100 (CERVICAL TRACTION ORTHOSIS 100)

    K Number: K861470 · Decision May 2, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    19
    Applicant Total
    1
    Review Days
    10

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    Basic Information

    Device Name
    #CTO 100 (CERVICAL TRACTION ORTHOSIS 100)
    K Number
    K861470
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5960
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Applied Medical Systems
    Date Received
    April 22, 1986
    Decision Date
    May 2, 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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