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    K Number
    K993381
    Device Name
    TONGUE STABILIZER DEVICE
    Manufacturer
    UNIVERSITY OF OTAGO
    Date Cleared
    1999-12-21

    (75 days)

    Product Code
    LRK
    Regulation Number
    872.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNIVERSITY OF OTAGO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To be used for the treatment of simple snoring in both dentate and edentult patientis. Can be used also for the treatment of snoring in patients with periodontically comprised dentitions and likewise patients presenting with Tempero-mandibular Dysfunction (TMD). Cephalometric and videoendoscopy studies have established that tongue protrusion creates a greater, increase in oropharyIngeal, velopharyngeal and hypopharyngeal cross-sectional areas of the upper airway, hence improving airway patency and function.
    Device Description
    TONGUE STABILIZING DEVICE
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