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U.S. Department of Health and Human Services

Product Classification

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Device expiratory resistance valve, intranasal, for obstructive sleep apnea
Regulation Description Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
Definition Intranasal device that creates expiratory resistance for the treatment of obstructive sleep apnea.
Physical State plastic with adhesive; valve that changes position with inspiration/expiration to provide decreased/increased resistance
Technical Method intranasal device that creates expiratory resistance
Target Area inserted into nares of nose to maintain upper airway pressure.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeOHP
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Dental Devices Branch (DEDB)
Submission Type 510(k)
Regulation Number 872.5570
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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