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510(k) Data Aggregation

    K Number
    K133554
    Device Name
    SURGICAL LIGHT HANDLE COVER
    Manufacturer
    MICROTEK MEDICAL, INC. AN ECOLAB COMPANY
    Date Cleared
    2014-04-08

    (140 days)

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

    MICROTEK MEDICAL, INC. AN ECOLAB COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A device intended to be used as a disposable barrier for a surgical lighting system and which allows a surgical team member to manually adjust the lighting system. This is a single-use device
    Device Description
    The Surgical Light Handle Cover is a polycarbonate injection molded device shaped to fit a surgical light that has release buttons protruding from the surgical light handle. The Surgical Light Handle Cover has apertures located at the end of the device, proximal to the surgical light, which correspond to the release buttons on the surgical light handle. When the Surgical Light Handle Cover is attached to the light, the release buttons will interface with the apertures to secure the Surgical Light Handle Cover to the light handle. The Surgical Light Handle Cover is hollow in the center, with transparent polycarbonate located near the distal end. The transparent end permits the use of a recording device, which may be mounted onto the surgical light. The transparent end allows light to pass through for the purpose of recording images, it does not provide image enhancement or magnification.
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