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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prelude tongue suspension system
Regulation Description Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
Definition Intended to be used for anterior advancement of the tongue base by means of a bone screw threaded with a suture. It is indicated for the treatment of obstructive sleep apnea (OSA) and/or snoring.
Product CodeORY
Regulation Number 872.5570
Device Class 2

Device Problems
No Known Device Problem 10
Total Device Problems 10