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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pouch, colostomy
Regulation Description Ostomy pouch and accessories.
Product CodeEZQ
Regulation Number 876.5900
Device Class 1


Premarket Reviews
ManufacturerDecision
COLOPLAST MANUFACTURING US LLC
  SUBSTANTIALLY EQUIVALENT 1
CONVATEC LIMITED
  SUBSTANTIALLY EQUIVALENT 1

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 1 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Convatec Inc. III Oct-18-2010

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