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    K Number
    K013668
    Device Name
    BERCHTOLD ELEKTROTOM 106 HITT
    Manufacturer
    BERCHTOLD CORP.
    Date Cleared
    2002-02-04

    (90 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    BERCHTOLD CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is intended for the coagulation of soft tissue during percutaneous, laparoscopic and intraoperative surgical procedures.
    Device Description
    The BERCHTOLD ELEKTROTOM® 106 HiTT® is an electrosurgical system consisting of a high frequency energy generator, syringe pump, needle applicators and accessories.
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