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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device laser, ent microsurgical carbon-dioxide
Regulation Description Ear, nose, and throat microsurgical carbon dioxide laser.
Product CodeEWG
Regulation Number 874.4500
Device Class 2


Premarket Reviews
ManufacturerDecision
AMERICAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
LUMENIS, INC.
  SUBSTANTIALLY EQUIVALENT 1

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