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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
  1.  K003908  SEROJET
  2.  K050734  COOL.CLICK
  3.  K090003  ZETAJET
  4.  K861687  BIOJECTOR SYRINGE SYSTEM
  5.  K920631  BIOJECT JET INJECTION SYSTEM
  6.  K960373  BIOJECTOR 2000 MODEL 1B02000
  7.  K994384  CLICKER
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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