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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device refrigerant, topical (vapocoolant)
Product CodeMLY
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
DUKAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
GEBAUER CO.
  SUBSTANTIALLY EQUIVALENT 7

Device Problems
No Known Device Problem 4
Total Device Problems 4

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 1 0 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 Gebauer Company II Nov-12-2008
2 Gebauer Company II Jul-23-2007

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