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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device syringe, ent
Regulation Description Ear, nose, and throat drug administration device.
Product CodeKCP
Regulation Number 874.5220
Device Class 1


Premarket Reviews
ManufacturerDecision
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 1
No code available 1
Total Device Problems 2

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 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0


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