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510(k) Data Aggregation

    K Number
    K050592
    Device Name
    SOMNOMED MAS RXA
    Manufacturer
    SOMNOMED LTD
    Date Cleared
    2005-07-12

    (126 days)

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

    SOMNOMED LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SomnoMed MAS RxA is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
    Device Description
    The Somnomed MAS RxA is an intraoral device used for treating Snoring and Sleep Apnea. It consists of two custom fitted trays which fit over the upper and lower teeth and which are positioned in relation to each other by an adjustable mechanism consisting of adjustable lugs. The device functions as a mandibular advancement device and enlarges the patient's pharyngeal space, improving their ability to exchange air during sleep. The device is custom made for each patient and has the adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device.
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