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    K Number
    K020310
    Device Name
    DAVLITE MICROENDOSCOPE & ACCESSORIES
    Manufacturer
    DAVLITE TECHNOLOGIES
    Date Cleared
    2002-03-20

    (50 days)

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

    DAVLITE TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is to be used by a physician for viewing an interior cavity of the human body through either a natural opening or an incision.
    Device Description
    The Davlite Microendoscope is a semi-rigid fiberscope with a single use sheath and a re-useable (reposable) microendoscope. The microendoscope is provided and labeled nonsterile. The microendoscope must be sterilized prior to use. (See instructions for cleaning and sterilization).
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