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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device implant, orbital, extra-ocular
Regulation Description Extraocular orbital implant.
Product CodeHQX
Regulation Number 886.3340
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOVASCULAR INC
  SUBSTANTIALLY EQUIVALENT 1
MIRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
OCULO PLASTIK, INC.
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
Electro-magnetic interference (EMI) 1
Total Device Problems 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 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0


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