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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bone marrow processing device to support hematopoietic reconstitution
Definition Processing of bone marrow harvested from human donors to support hematopoietic reconstitution in a recipient.
Product CodePKG
Regulation Number 864.9245
Device Class 2


Premarket Reviews
ManufacturerDecision
TERUMO BCT, INC
  SUBSTANTIALLY EQUIVALENT 1

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