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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device applicator (laryngo-tracheal), topical anesthesia
Regulation Description Laryngotracheal topical anesthesia applicator.
Product CodeCCT
Regulation Number 868.5170
Device Class 2


Premarket Reviews
ManufacturerDecision
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Crack 2
Total Device Problems 2

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 1 0 0 0 0 0 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Sharn, Inc. II Nov-16-2009
2 Teleflex Medical II Nov-09-2016

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