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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device apparatus, cutting, radiofrequency, electrosurgical, ac-powered
Regulation Description Radiofrequency electrosurgical cautery apparatus.
Definition Used to perform anterior capsulotomy during cataract surgery
Product CodePUL
Regulation Number 886.4100
Device Class 2


Premarket Reviews
ManufacturerDecision
CENTRICITY VISION, INC.
  SUBSTANTIALLY EQUIVALENT 3

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