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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 component 4
Detachment of device or device component 4
Break 3
Device packaging compromised 1
No Known Device Problem 1
Component falling 1
Corrosion 1
Failure to power-up 1
Product quality issue 1
Device or device fragments location unknown 1
Total Device Problems 18

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