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510(k) Data Aggregation

    K Number
    K013687
    Device Name
    NOSE BREATHE MOUTHPIECE FOR HEAVY SNORER
    Manufacturer
    STEVEN K. SUE
    Date Cleared
    2002-05-28

    (202 days)

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

    STEVEN K. SUE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    It is a prescription device intended to reduce snoring.
    Device Description
    A prescription anti-snoring mouthpiece that is similar in design and purpose as the Samelson device. The tongue is placed at the roof of the mouth with a tongue platform holding the tongue in the forward position by a naturally occurring tongue suction and lip seal. It requires upper and lower molds. It is constructed of flexible, thermoforming mouthguard materials.
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