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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device saliva, artificial
Product CodeLFD
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
FRESENIUS
  SUBSTANTIALLY EQUIVALENT 1
GEBAUER CO.
  SUBSTANTIALLY EQUIVALENT 1
GLAXOSMITHKLINE
  SUBSTANTIALLY EQUIVALENT 1
KINGSWOOD LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
SINCLAIR PHARMACEUTICALS, LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Information 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 1 0 0 0 0 0 1 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Gebauer Company II Mar-20-2007
2 GlaxoSmithKline, LLC. II Nov-13-2013

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