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    K Number
    K080550
    Device Name
    MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22
    Manufacturer
    MINOS MEDICAL
    Date Cleared
    2008-06-10

    (103 days)

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

    MINOS MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Megachannel Endoscopic Overtube is indicated for use in conjunction with an endoscope for tissue or foreign body manipulations and/or where multiple removal and reinsertions of the endoscope are required.
    Device Description
    The Megachannel Endoscopic Overtube is a disposable flexible PVC tube that is to be used with an endoscope. The overtube includes a proximal handle with insufflation sealing cap that accommodates a standard 12.8 mm diameter colonoscope. A removable introducer plug is attached to the distal tip to facilitate the introduction of the overtube through the gastrointestinal tract.
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