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510(k) Data Aggregation

    K Number
    K981923
    Device Name
    THE SNORE PEACE
    Date Cleared
    1998-08-24

    (84 days)

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

    THE SNORE PEACE GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To reduce or alleviate snoring by holding the tongue and lower jaw in a 60-75% of patient maximum protrusion forward position during sleep.
    Device Description
    The Snore Peace® is a single piece device which is form custom fitted to the users upper and lower teeth and inner lips. It is meant to be worn at night while sleeping.
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