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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search Show TPLC since Back To Search Results
Device unit, cryophthalmic, ac-powered
Regulation Description Cryophthalmic unit.
Product CodeHRN
Regulation Number 886.4170
Device Class 2


Premarket Reviews
ManufacturerDecision
DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV
  SUBSTANTIALLY EQUIVALENT 1
PHAKOS
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Difficult to Remove 1
Device Operates Differently Than Expected 1
Total Device Problems 2


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