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510(k) Data Aggregation

    K Number
    K183374
    Device Name
    GrayDuck Stent
    Manufacturer
    Date Cleared
    2019-02-26

    (82 days)

    Product Code
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    POLL Medical LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The GrayDuck Stent™ custom tongue and jaw positioner from POLL Medical LLC is intended to be used for repeat positioning and immobilization of a patient's tongue and jaw while undergoing or receiving a course of external beam radiation therapy for treatment of cancer and other diseases. The GrayDuck Stent is intended to be used by or under the direction of a licensed physician.
    Device Description
    The GrayDuck Stent™ custom tongue and jaw positioner from POLL Medical is design to provide reproducible opening of the jaw and positioning of the tongue for a patient undergoing external beam radiation therapy treatment. In addition, the GrayDuck Stent provides shielding against secondary low-energy backscatter radiation emitted from metal fillings and bridgework. The stent is a custom-fitted bite block with a boil-and-bite insert that allows for formation of dental impressions for repeatable positioning. The Stent is made of an injection molded plastic material with moldable EVA bite inserts. The GrayDuck Stent is available in two sizes. The patient's tongue can be deviated laterally left, laterally right, downward (depressed), or a combination of laterally left/depressing or laterally right/depressing by using one of the GrayDuck Stent tongue paddles, which allows many degrees of freedom in positioning the patient's tongue and jaw.
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