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    K Number
    K093718
    Device Name
    ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003
    Manufacturer
    ZUTRON MEDICAL LLC
    Date Cleared
    2010-02-22

    (82 days)

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

    ZUTRON MEDICAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Zutron Medical ZUTR-1003 Endoscope Leak Tester is designed to detect interior and exterior leaks in endoscopes.
    Device Description
    The Zutron Medical Endoscope Leak Tester is a leak testing device that detects damage to the interior or exterior of an endoscope.
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    K Number
    K051068
    Device Name
    ZUTRON COLONOSCOPE STIFFENING DEVICE
    Manufacturer
    ZUTRON MEDICAL
    Date Cleared
    2005-07-11

    (76 days)

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

    ZUTRON MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of the device is to allow the physician to increase the stiffness of the colonoscope when extra rigidity is required.
    Device Description
    The Zutron Colonoscope Stiffening Device performs the same functions as several other devices on the market. Additionally, the subject device is composed of the same materials and has similar dimensions to some of the predicate devices.
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