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510(k) Data Aggregation

    K Number
    K111342
    Device Name
    LIGHT GUIDE CABLE
    Manufacturer
    SCHOTT NORTH AMERICA
    Date Cleared
    2011-11-25

    (196 days)

    Product Code
    HBI
    Regulation Number
    878.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCHOTT NORTH AMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Schott Light Guide Cable is indicated for use in transmitting light for illumination purposes from an illuminator to various instruments such as headlights, microscopes and endoscopes, providing illumination in body cavities during examinations or surgical procedures.
    Device Description
    The Light guide cable consists of glass fibers which are glued or fused into ferrules on both ends. The ends are polished to effectively transmit light and are equipped with standard endoscope connectors to transmit visible light from the light source to the intended instrument. The fibers are covered by Silicone sheathing for ease of handling and protecting the fibers from damage. The device is intended to be Ethylene Oxide (EtO) sterilized by the user. Sterilization information is contained in section 14.
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