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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, dialysate delivery, sorbent regenerated
Regulation Description Sorbent regenerated dialysate delivery system for hemodialysis.
Product CodeFKT
Regulation Number 876.5600
Device Class 2


Premarket Reviews
ManufacturerDecision
ASH
  SUBSTANTIALLY EQUIVALENT 3
GAMBRO
  SUBSTANTIALLY EQUIVALENT 1
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 8

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