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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
VENTUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 1 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Ventus Medical, Inc. III Feb-15-2012

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