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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device set, transfer (blood/plasma)
Regulation Description Transfer set.
Product CodeKSB
Regulation Number 864.9875
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
CHARTER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
  1.  BK050021  Transfer Sets
FRESENIUS
  SUBSTANTIALLY EQUIVALENT 1
FUTURE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
HAEMONETICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 8

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