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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device case, contact lens
Regulation Description Soft (hydrophilic) contact lens care products.
Product CodeLRX
Regulation Number 886.5928
Device Class 2


Premarket Reviews
ManufacturerDecision
ALCON
  SUBSTANTIALLY EQUIVALENT 3
ALLERGAN, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAUSCH & LOMB, INC.
  SUBSTANTIALLY EQUIVALENT 2
BONASSE ENT. CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CIBA VISION
  SUBSTANTIALLY EQUIVALENT 2
MMAGLA PRODUCTS INCAGNIVISION, INC.
  SUBSTANTIALLY EQUIVALENT 6
NINGBO KAIDA RUBBER AND PLASTIC TECHNOLOGY CO., LT
  SUBSTANTIALLY EQUIVALENT 1
PARAGON VISION SCIENCES
  SUBSTANTIALLY EQUIVALENT 3
SAUFLON PHARMACEUTICALS, LTD.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Artifact 1
Total Device Problems 1

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