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    K Number
    K160531
    Device Name
    Noiselezz
    Manufacturer
    FIRMA INGEMARSSON
    Date Cleared
    2016-09-01

    (189 days)

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

    FIRMA INGEMARSSON

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Noiselezz® is intended for the treatment of nighttime snoring in adults.
    Device Description
    The Noiselezz® Mouthpiece is an Anti-Snoring device consisting of Two trayed plates fitted in front and between the upper and lower teeth and gums and integrated with each other with the same material as the upper and lower plates. The device is made of Thermoplastic elastomer May be used as supplied
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