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510(k) Data Aggregation

    K Number
    K960400
    Device Name
    DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS)
    Manufacturer
    SNOWDEN-PENCER
    Date Cleared
    1996-03-12

    (43 days)

    Product Code
    FBM, GCJ, GEI
    Regulation Number
    876.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    SNOWDEN-PENCER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Various endoscopic surgical instruments for use in minimally invasive cardiac procedures including single bypass and multiple bypass (coronary artery bypass grafting (CABG)procedures), and saphenous vein harvesting.
    Device Description
    The devices are separated into several groups: endoscopes, endoscopic needle holders, endoscopic graspers and clamps, endoscopic scissors, endoscopic knife blade handles, hooks and clip appliers, endoscopic irrigation probes, endoscopic electrodes, retractors and rib spreaders, thoraports and cannulas.
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