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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device hemostatic wound dressing without thrombin or other biologics
Definition To temporarily control bleeding and cover external wounds.
Product CodeQSY
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
ADVAMEDICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
CRESILON, INC.
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU ZEO-INNOV LIFE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INCORE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRADE PRODUCTS , LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOLAPLUS BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
STARCH MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
USHARE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

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