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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
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

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