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    K Number
    K073616
    Device Name
    FAS-CLEAN ELECTROSURGICAL COATED ACTIVE BLADE
    Manufacturer
    ELECTROMEDICS CO. LTD.
    Date Cleared
    2008-07-23

    (210 days)

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

    ELECTROMEDICS CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FAS-CLEAN Electrosurgical Coated Active Blade, a single use, sterile, monopolar, Emralon coated electrode is intended for use: - In surgical procedures (general, neurosurgical, laparoscopic, orthopedic, and gynecological) where monopolar electrosurgical cutting and coagulation are normally used. - As an alternative to uncoated stainless steel electrodes or "non-stick" coated electrodes, which are used for these indications.
    Device Description
    ELECTROMEDICS' FAS-CLEAN Electrosurgical Coated Active Blade is a sterile, single use, coated stainless steel blade. The main parts of the device are the Emralon coated stainless steel blade and the insulated polyethylene sleeve.
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