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510(k) Data Aggregation

    K Number
    K132771
    Device Name
    KINGSTON ENDOSCOPIC SURGICAL INSTRUMENTS
    Manufacturer
    QINGDAO KINGSTON MEDICAL DEVICES LTD
    Date Cleared
    2014-10-28

    (418 days)

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

    QINGDAO KINGSTON MEDICAL DEVICES LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Endoscopic Surgical Instruments are intended for cutting, grasping, dissecting and coagulation of soft tissue in endoscopic surgical procedures. They are intended for single patient use.
    Device Description
    The Endoscopic Surgical Instruments are disposable,single use,individually packaged devices that are composed of biocompatible materials. The instruments are 5mm in diameter as well as 330mm (or 420mm) in length. The instruments consist of handle, shaft and dissector /grasper/scissor jaw.
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