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510(k) Data Aggregation

    K Number
    K972057
    Device Name
    POWERTREK INSTRUMENTS
    Manufacturer
    Date Cleared
    1997-11-05

    (156 days)

    Product Code
    Regulation Number
    874.4250
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTREK CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PowerTREK Instrument is indicated for use in the removal of tissue or bone in minimally invasive ENT and ,Orthopedic procedures. It is to be used within a surgical setting under sterile technique.
    Device Description
    Not Found
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