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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device laser, neodymium:yag, pulmonary surgery
Regulation Description Ear, nose, and throat microsurgical carbon dioxide laser.
Product CodeLLO
Regulation Number 874.4500
Device Class 2


Premarket Reviews
ManufacturerDecision
LASER PERIPHERALS LLC.
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL LASER TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
TRIMEDYNE, INC.
  SUBSTANTIALLY EQUIVALENT 1

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