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510(k) Data Aggregation

    K Number
    K083710
    Device Name
    RETRACTOR LITE
    Date Cleared
    2009-02-23

    (70 days)

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

    THOMAS SURGICAL INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Thompson Surgical Instruments, Inc. Retractor Lite intended as a task light for surgical procedures. It is designed to be used in conjunction with a retractor blade which it can attach to through the use of TECASONTM P XRO clips. The Retractor Lite is designed to provide visible illumination of the surgical field or the patient through a Xenon light source only. The Retractor Lite is designed to be used by surgeons and other medical care practitioners in a surgical setting.
    Device Description
    Thompson Surgical Instruments. Inc. Retractor Lite is a fiber optic surgical light designed to provide visible illumination of the surgical field or the patient. The Retractor Lite consists of a flexible "gooseneck" supported lighthead for easy positioning, a fiber optic bundle, and two molded clips made of TECASONTM P XRO used to attach the gooseneck portion of the light to a retractor blade. The Thompson surgical Retractor Lite is designed as a task light for surgical use.
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