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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device peripheral blood processing device for wound management
Regulation Description Automated blood cell separator.
Definition Preparation of autologous platelet rich plasma gel from a small sample of peripheral blood for wound management.
Product CodePMQ
Regulation Number 864.9245
Device Class 2


Premarket Reviews
ManufacturerDecision
INNOVEREN SCIENTIFIC INC.
  SUBSTANTIALLY EQUIVALENT 1
MIMIX BIOTHERAPEUTICS, LTD
  SUBSTANTIALLY EQUIVALENT 1
REAPPLIX APS
  SUBSTANTIALLY EQUIVALENT 1
REDDRESS LTD
  SUBSTANTIALLY EQUIVALENT 1
REGENLAB SA
  SUBSTANTIALLY EQUIVALENT 1

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