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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device light, surgical, endoscopic
Regulation Description Surgical lamp.
Product CodeFSW
Regulation Number 878.4580
Device Class 2


Premarket Reviews
ManufacturerDecision
GENZYME CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL ILLUMINATION
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1

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