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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device culdoscope (and accessories)
Regulation Description Culdoscope and accessories.
Product CodeHEW
Regulation Number 884.1640
Device Class 2


Premarket Reviews
ManufacturerDecision
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 1
COOPERSURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 3
LSI SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
MAXXIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Component falling 1
No Known Device Problem 1
Total Device Problems 2

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