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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device microtools, assisted reproduction (pipettes)
Regulation Description Assisted reproduction microtools.
Product CodeMQH
Regulation Number 884.6130
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 5
IRVINE SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
MID-ATLANTIC DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
RESEARCH INSTRUMENTS LTD.
  SUBSTANTIALLY EQUIVALENT 2
Sunlight Medical, Inc.
  SUBSTANTIALLY EQUIVALENT 2
SWEMED LAB INTERNATIONAL AB
  SUBSTANTIALLY EQUIVALENT 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 2 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Cook Vascular Inc. II Sep-18-2008
2 Cook Vascular Inc. II Sep-16-2008

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