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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pump, infusion or syringe, extra-luminal
Regulation Description Hemodialysis system and accessories.
Product CodeFIH
Regulation Number 876.5820
Device Class 2


Premarket Reviews
ManufacturerDecision
E-Z-EM, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Component(s), broken 1
Total Device Problems 1

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