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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device injector, fluid, non-electrically powered
Regulation Description Nonelectrically powered fluid injector.
Product CodeKZE
Regulation Number 880.5430
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOJECT, INC.
  SUBSTANTIALLY EQUIVALENT 7
MADA EQUIPMENT CO.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL HOUSE PRODUCTS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SYNERGETICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 0 1 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 CaridianBCT, Inc. II May-11-2012

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