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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 products, contact lens care, rigid gas permeable
Regulation Description Rigid gas permeable contact lens care products.
Product CodeMRC
Regulation Number 886.5918
Device Class 2


Premarket Reviews
ManufacturerDecision
BAUSCH & LOMB, INC.
  SUBSTANTIALLY EQUIVALENT 2
CONTAMAC LTD.
  SUBSTANTIALLY EQUIVALENT 1
MENICON CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Adverse Event Without Identified Device or Use Problem 4
Device Operates Differently Than Expected 1
Total Device Problems 5


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