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    K Number
    K972984
    Device Name
    LERNER MEDICAL, INC. AUTOCLAVABLE 10 MM LAPAROSCOPE
    Manufacturer
    LERNER MEDICAL, INC.
    Date Cleared
    1997-10-29

    (79 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    LERNER MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The I emer Medical, Inc. Autoclavable 10MM Laparoscope is intended to be used for visualization of the abdominal cavity during general and thoracic surgery. General Surgery - Laparoscopic cholecystectorny, liernia repair, Appendcctomy, Nissen fundal plication, . Diagnosis and Management of acute abdomen Thoracic Surgery - Pericardiectorny, Pneumonectomy, Evaluation of pulmonary nodule, Biopsy, Pleurodosis
    Device Description
    The Lemer Medical. Inc. Autoclavable 10MM Laparoscope System is a 10MM diameter laparoscope which may be used during diagnostic and operative laparoscopy procedures for visualization of the abouninal cavity. The laparoscope may be disinfected using bigh level disinfectants or sterilized using ethylene oxide gas or steam autoclave.
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