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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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.
Product CodeOHP
Regulation Number 872.5570
Device Class 2


Premarket Reviews
ManufacturerDecision
BRYGGS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
  1.  K191728  ULTepap Expiratory Positive Airway Pressure (EPAP) ...

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems II May-29-2020
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