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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
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
REAPPLIX APS
  SUBSTANTIALLY EQUIVALENT 3
REDDRESS LTD
  SUBSTANTIALLY EQUIVALENT 4
  1.  BK170095  Peripheral blood processing device for wound manag ...
  2.  BK190349  Peripheral blood processing device for wound manag ...
  3.  BK200464  Peripheral blood processing device for wound manag ...
  4.  BK210570  Peripheral blood processing device for wound manag ...
REGENLAB SA
  SUBSTANTIALLY EQUIVALENT 1

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