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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device sponge, ophthalmic
Regulation Description Ophthalmic sponge.
Product CodeHOZ
Regulation Number 886.4790
Device Class 2


Premarket Reviews
ManufacturerDecision
ALCON
  SUBSTANTIALLY EQUIVALENT 1
DEROYAL
  SUBSTANTIALLY EQUIVALENT 1
HURRICANE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
KATENA PRODUCTS, INC
  SUBSTANTIALLY EQUIVALENT 1
LONGTEK SCIENTIFIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHIPPERT MEDICAL TECHNOLOGIES CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Reaction 3
Total Device Problems 3

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


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