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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device illuminator, fiberoptic, surgical field
Regulation Description Surgical lamp.
Product CodeHBI
Regulation Number 878.4580
Device Class 2


Premarket Reviews
ManufacturerDecision
ASPEN LABORATORIES
  SUBSTANTIALLY EQUIVALENT 2
GULF MEDICAL FIBEROPTICS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 1
Total Device Problems 1

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