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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device drain, tee (water trap)
Regulation Description Tee drain (water trap).
Product CodeBYH
Regulation Number 868.5995
Device Class 1


Premarket Reviews
ManufacturerDecision
BALLARD MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
Ventlab Corporation
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Leak 12
Aspiration, excessive 1
Disengaged 1
Total Device Problems 14

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 0 0 0 0 0


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