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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device disinfectant, subsystem, water purification
Regulation Description Water purification system for hemodialysis.
Definition Disinfectant intended for reprocessing water purification systems for hemodialysis.
Product CodeNIH
Regulation Number 876.5665
Device Class 2


Premarket Reviews
ManufacturerDecision
MEDIVATORS REPROCESSING SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

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