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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device marker, ostia, aorto-saphenous vein
Product CodeKPK
Regulation Number 878.4650
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
SCANLAN
  SUBSTANTIALLY EQUIVALENT 1

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