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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device strip, test, reagent, residuals for dialysate, disinfectant
Regulation Description Water purification system for hemodialysis.
Product CodeMSY
Regulation Number 876.5665
Device Class 2


Premarket Reviews
ManufacturerDecision
NELSON ENVIRONMENTAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
REPROCESSING PRODUCTS CORPORATION (RPC)
  SUBSTANTIALLY EQUIVALENT 1

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