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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, rebreathing
Regulation Description Rebreathing device.
Product CodeBYW
Regulation Number 868.5675
Device Class 1


Premarket Reviews
ManufacturerDecision
KENDALL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Air leak 1
Other (for use when an appropriate device code cannot be identified) 1
Total Device Problems 2

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0


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