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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device led light source
Regulation Description Endoscope and accessories.
Definition Used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals
Product CodeNTN
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 2
OPTIM, INC.
  SUBSTANTIALLY EQUIVALENT 1
SOPRO
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Detachment of device component 1
Total Device Problems 1

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