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510(k) Data Aggregation

    K Number
    K991209
    Device Name
    ORAL SLEEP DISORDER AID
    Manufacturer
    PERL-RAD SLEEP DISORDER LAB
    Date Cleared
    1999-09-22

    (166 days)

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

    PERL-RAD SLEEP DISORDER LAB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A maxillary "denture-like" mouthpiece with tongue restraint compartment to actuate mouth closure. The device is intended for use as an aid to reduce simple snoring. It is customized for patients with or without natural teeth and for mixed dentition. Reflex action reverts to mouth breathing instantly should the nasal passages congest
    Device Description
    A maxillary "denture-like" mouthpiece with tongue restraint compartment to actuate mouth closure.
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