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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cannula, sinus
Regulation Description Manual surgical instrument for general use.
Product CodeKAM
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
ACCLARENT, INC.
  SUBSTANTIALLY EQUIVALENT 8
BOSTON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MICROMEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
XOMED, INC.
  SUBSTANTIALLY EQUIVALENT 3

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