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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device telescope, rigid, endoscopic
Regulation Description Endoscope and accessories.
Product CodeFBP
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
ACMI CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No display or display failure 25
Image resolution poor 3
Compatibility 3
Break 1
Poor quality image 1
Normal 1
Output energy incorrect 1
Use of Device Issue 1
Device Issue 1
Arcing 1
No Information 1
Total Device Problems 39

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