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510(k) Data Aggregation
K Number
K050592Device Name
SOMNOMED MAS RXA
Manufacturer
SOMNOMED LTD
Date Cleared
2005-07-12
(126 days)
Product Code
LRK
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
SOMNOMED LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SomnoMed MAS RxA is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
Device Description
The Somnomed MAS RxA is an intraoral device used for treating Snoring and Sleep Apnea. It consists of two custom fitted trays which fit over the upper and lower teeth and which are positioned in relation to each other by an adjustable mechanism consisting of adjustable lugs. The device functions as a mandibular advancement device and enlarges the patient's pharyngeal space, improving their ability to exchange air during sleep. The device is custom made for each patient and has the adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device.
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