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510(k) Data Aggregation

    K Number
    K082849
    Device Name
    SILENT SLEEP
    Date Cleared
    2009-07-16

    (290 days)

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

    CRANIOFACIAL PAIN CENTER OF IDAHO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    1. For the temporary or trial treatment of snoring and mild to moderate obstructive sleep apnea in adults over age 18. The Silent Sleep is not intended to be used for more than 30 days.
    Device Description
    Not Found
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