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

    FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM

    K Number: K980689 · Decision Feb 18, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    19
    Applicant Total
    1
    Review Days
    360

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    Basic Information

    Device Name
    FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM
    K Number
    K980689
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5960
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Friddle'S Orthopedic Appliances, Inc.
    Date Received
    February 23, 1998
    Decision Date
    February 18, 1999
    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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