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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, biliary, reprocessed
Regulation Description Biliary catheter and accessories.
Definition same as "FGE" except being reprocessed.
Product CodeNML
Regulation Number 876.5010
Device Class 2


Premarket Reviews
ManufacturerDecision
STERILMED
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Source, detachment from 1
Total Device Problems 1

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 1 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Sterilmed Inc II Jan-13-2009

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