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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?
    Product Code :

    FCY

    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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