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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device protector, transducer, dialysis
Regulation Description Hemodialysis system and accessories.
Product CodeFIB
Regulation Number 876.5820
Device Class 2


Premarket Reviews
ManufacturerDecision
BIPORE, INC.
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS
  SUBSTANTIALLY EQUIVALENT 2
GAMBRO
  SUBSTANTIALLY EQUIVALENT 1
MEDISYSTEM
  SUBSTANTIALLY EQUIVALENT 3
MILLIPORE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NIPRO CORP
  SUBSTANTIALLY EQUIVALENT 3
PALL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

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