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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device syringe, cartridge
Regulation Description Cartridge syringe.
Product CodeEJI
Regulation Number 872.6770
Device Class 2


Premarket Reviews
ManufacturerDecision
HAGER WORLDWIDE, INC.
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
MILTEX
  SUBSTANTIALLY EQUIVALENT 1
ULTRADENT PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Information 2
Device Cleaning Issue 1
Disconnection 1
Connection issue 1
Unintended movement 1
Total Device Problems 6

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


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