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510(k) Data Aggregation

    K Number
    K993358
    Device Name
    SIGHTSURE OPERATION INDICATOR, MODEL SS301
    Manufacturer
    Date Cleared
    2000-03-15

    (161 days)

    Product Code
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SightSure® Operation Indicator is indicated for use as an accessory to a dual lumen gastrointestinal sump tube with an air vent lumen which allows for a visual monitor of proper functioning of the tube during medical use.
    Device Description
    The device is characterized by a chamber that is filled with sterile water prior to use. Negative pressure provided by a functioning dual lumen medical tube vent lumen is applied to the chamber through a tube linking the vent (sump) lumen to the sealed chamber. Atmospheric equilibration of the chamber is provided through a capillary vent that has its distal end in the liquid media. Equilibration of the chamber results in flow of atmospheric air into the capillary tube and subsequent egress of bubbles in the liquid media of the device indicates proper functioning of the dual lumen tube.
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