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    K Number
    K112205
    Device Name
    SNORERX 9.0
    Manufacturer
    CONSUMER HEALTH PRODUCTS, INC
    Date Cleared
    2011-11-16

    (107 days)

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

    CONSUMER HEALTH PRODUCTS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Consumer Health Products "SnoreRx NS 9.0" is intended for use on adult patients 18 years of age or older as an aid for the reduction of snoring.
    Device Description
    The Consumer Health Products SnoreRx NS 9.0 is an intraoral device used at night to reduce snoring by advancing the lower jaw and thereby minimizing air obstruction and turbulence. The device consists of two custom fabricated trays that fit separately over the upper and lower dental arches and engage each other in the anterior area of the mouth. This interface, and thus this device, functions as a mandibular anterior repositioner, which acts to increase the patient's pharyngeal space, improving the ability to exchange air during sleep
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