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510(k) Data Aggregation

    K Number
    K161980
    Device Name
    Fuselier Intraoral Nighttime Device (FIND)
    Date Cleared
    2017-02-07

    (204 days)

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

    FUSELIER ENTERPRISES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A patient specific mandibular repositioning device intended to reduce or alleviate night-time snoring and mild to moderate obstructive sleep apnea in adult patients 18 years or older.
    Device Description
    The Fuselier Intraoral Nighttime Device (FIND) is a patient specific oral device intended to mitigate night-time snoring and mild to moderate obstructive sleep apnea. The function of the FIND is to continuously hold the mandible in an advanced position to prevent the tongue from compressing against the oropharyngeal wall keeping the airway open during sleep. The principle of advancing a lower tray is to advance the mandible for the treatment of night-time snoring and / or mild to moderate obstructive sleep apnea.
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