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510(k) Data Aggregation
K Number
K112766Device Name
SNORKEL
Manufacturer
FELLMAR COMPANY
Date Cleared
2012-06-04
(256 days)
Product Code
LQZ
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
FELLMAR COMPANY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Snorkel is used to reduce tongue induced airway obstructions. The Snorkel is intended for use in patients, for the treatment of mild to moderate obstructive sleep apnea.
Device Description
The Snorkel is an oral mandibular advancement device whose function is to artificially protrude the chin (mandible) forward so as to pull the tongue away from the back of the throat, thereby reducing tongue-induced airway obstruction.
The Snorkel device is custom-made and fitted based on dental impressions and used by the patient during sleep. The single mouth piece fits snugly onto the upper and lower crowns of the patient's teeth. As the patient falls asleep, thus relaxing their mandible, a silicon band provides tension such that the mandible is pulled forward along with the tongue.
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