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510(k) Data Aggregation
K Number
K161980Device Name
Fuselier Intraoral Nighttime Device (FIND)
Manufacturer
Date Cleared
2017-02-07
(204 days)
Product Code
Regulation Number
872.5570Why 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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