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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
FRESENIUS
  SUBSTANTIALLY EQUIVALENT 1
FUTURE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
HAEMONETICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 8
  1.  BK040082  Transfer Sets
  2.  BK070018  Transfer Sets
  3.  BK110071  Transfer Sets
  4.  BK860012  Transfer Sets
  5.  BK860041  Transfer Sets
  6.  BK890032  Transfer Sets
  7.  BK900028  Transfer Sets
  8.  BK970008  Transfer Sets

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