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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dressing,wound,hydrogel w/out drug and/or biologic
Regulation Description Hydrogel wound dressing and burn dressing.
Product CodeNAE
Regulation Number 878.4022
Device Class 1


Premarket Reviews
ManufacturerDecision
GORBEC PHARMACEUTICAL SERVICES, INC.
  SUBSTANTIALLY EQUIVALENT 2

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 1 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Embeem Inc. II Jan-17-2007

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