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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device filter, blood, dialysis
Regulation Description Hemodialysis system and accessories.
Product CodeFKJ
Regulation Number 876.5820
Device Class 2


Premarket Reviews
ManufacturerDecision
SERIM RESEARCH CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Filtration issue 32
Disconnection 5
Fluid leak 5
Ultrafiltration 4
Material separation 3
Device alarm system issue 2
Detachment of device component 1
Display misread 1
Failure to deliver 1
Device sensing issue 1
Leak 1
No Information 1
Total Device Problems 57

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