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    K Number
    K955717
    Device Name
    ENDOSCOPE INTRODUCER KIT
    Manufacturer
    MITSUBISHI CABLE AMERICA, INC.
    Date Cleared
    1996-04-18

    (122 days)

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

    MITSUBISHI CABLE AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mitsubishi Endoscope Introducer Kit is intended to provide an open channel to allow insertion of a small diameter endoscope during laparoscopic choledochoscopy.
    Device Description
    The Mitsubishi Endoscope Introducer Kit consists of an internal dilator (with luer fitting to accommodate a hemostasis valve) contained within an external sheath (with attached hemostasis valve and luer fitting). The dilator may be straight or curved and has a lumen to allow passage of a flexible guidewire.
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    K Number
    K960081
    Device Name
    BATTERY POWERED ENDOSCCOPIC LIGHT SOURCE
    Manufacturer
    MITSUBISHI CABLE AMERICA, INC.
    Date Cleared
    1996-03-12

    (61 days)

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

    MITSUBISHI CABLE AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mitsubishi Battery Powered Endoscopic Light Source is intended for use as a light source for diagnostic endoscopes.
    Device Description
    The Mitsubishi Battery Powered Endoscopic Light Source is a lightweight, portable, battery powered light source intended for use with diagnostic endoscopes. The light source is powered by one three-volt lithium battery contained within a leakproof case and controlled by a manual on/off switch. Illumination is provided by a 1.7-watt The unit may be connected by friction-fit to most manufacturers' halogen bulb. endoscopes via adaptors (supplied separately) that attach to the endoscope light cable post.
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