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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cover, barrier, protective
Regulation Description Surgical drape and drape accessories.
Product CodeMMP
Regulation Number 878.4370
Device Class 2


Premarket Reviews
ManufacturerDecision
CONTOUR FABRICATORS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU FORTUNIQUE LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 1
Contamination during use 1
Expiration date error 1
Total Device Problems 3

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 2 0 0 1 0 0 2 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 GE Medical Systems, LLC II Sep-01-2009
2 GE Medical Systems, LLC II Aug-14-2009
3 Metrex Research, LLC. II Nov-27-2012
4 Penner Mfg Inc II Mar-20-2015
5 Sybron Dental Specialties II Mar-18-2015

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