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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device anti fog solution and accessories, endoscopy
Regulation Description Endoscope and accessories.
Definition To prevent, reduce or eliminate condensation (fog) on endoscopic lens.
Product CodeOCT
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
DEROYAL
  SUBSTANTIALLY EQUIVALENT 1
MECTRA LABS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
OR SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
PRESERVATION SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
XODUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Detachment of device or device component 3
Total Device Problems 3

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