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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device perimeter, automatic, ac-powered
Regulation Description Perimeter.
Product CodeHPT
Regulation Number 886.1605
Device Class 1


Premarket Reviews
ManufacturerDecision
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 3
CARL ZEISS MEDITEC INC
  SUBSTANTIALLY EQUIVALENT 2
COOPERVISION
  SUBSTANTIALLY EQUIVALENT 1
NOTAL VISION, INC.
  SUBSTANTIALLY EQUIVALENT 1
SEEING MACHINES LIMITED
  SUBSTANTIALLY EQUIVALENT 1

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 0 0 0 0 1 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Haag-Streit USA Inc II Sep-20-2012

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