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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device surgical smoke precipitator
Regulation Description Surgical smoke precipitator.
Definition The device is intended to precipitate surgical smoke to allow surgeons adequately visualize laparoscopic surgeries in the using surgical smoke/aerosolized particulate surgical tools.
Product CodePQM
Regulation Number 878.5050
Device Class 2


Premarket Reviews
ManufacturerDecision
ALESI SURGICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ALESI SURGICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 2

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