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510(k) Data Aggregation

    K Number
    K071173
    Device Name
    RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D
    Manufacturer
    OSSUR AMERICANS (FORMERLY THE JEROME GROUP)
    Date Cleared
    2007-05-25

    (28 days)

    Product Code
    HAX
    Regulation Number
    882.5960
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSSUR AMERICANS (FORMERLY THE JEROME GROUP)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ReSolve Tongs are intended for use to provide longitudinal traction to align vertebral structures, maintain reduction, or provide stabilization for a cervical spine injury.
    Device Description
    The ReSolve Tongs are similar to other traction tongs which are used to provide longitudinal traction to align vertebral structures, maintain reduction, or provide stabilization for a cervical spine injury.
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