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    K Number
    K121285
    Device Name
    ORAVAN OSA
    Manufacturer
    NEW JERSEY SNORING SOLUTIONS
    Date Cleared
    2013-03-08

    (312 days)

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

    NEW JERSEY SNORING SOLUTIONS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Oravan OSA is intended to reduce snoring and mild to moderate sleep apnea in adults
    Device Description
    The Oravan OSA has been developed for the treatment of mild to moderate obstructive sleep apnea. Each Oravan device is made for each individual patient. There are two unique acrylic pieces that fit over the top and bottom teeth. The Oravan is fully adjustable for maximum benefit to treat the symptoms of obstructive sleep apnea and snoring. The Oravan sleek design allows for comfortable mandibular movement. The Oravan is made of orthodontic acrylic. Each device is warranted for 2 full years against breakage from everyday use.
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