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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tube, double lumen for intestinal decompression and/or intubation
Regulation Description Gastrointestinal tube and accessories.
Product CodeFEG
Regulation Number 876.5980
Device Class 2


Premarket Reviews
ManufacturerDecision
AXIOM
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
ICU MEDICAL SALES, INC.
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 2
  SUBSTANTIALLY EQUIVALENT - KIT 1
WILSON COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Knotted 5
Total Device Problems 5

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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