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

    RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D

    K Number: K071173 · Decision May 25, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    19
    Applicant Total
    1
    Review Days
    28

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    Basic Information

    Device Name
    RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D
    K Number
    K071173
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.5960
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ossur Americans (Formerly the Jerome Group)
    Date Received
    April 27, 2007
    Decision Date
    May 25, 2007
    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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