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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device syringe, irrigating (non dental)
Regulation Description Irrigating syringe.
Product CodeKYZ
Regulation Number 880.6960
Device Class 1


Premarket Reviews
ManufacturerDecision
MICROMEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 4
SHIPPERT MEDICAL TECHNOLOGIES CORP.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
SUB-Q, INC.
  SUBSTANTIALLY EQUIVALENT 2
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 1
WELCON, INC.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 1 0 0 0
Class II 0 0 0 0 0 2 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Customed, Inc II Mar-21-2012
2 Haemacure Corporation II May-11-2012
3 Micromedics, Inc. I Nov-18-2010

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