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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device surgical instruments, g-u, manual (and accessories)
Regulation Description Manual gastroenterology-urology surgical instrument and accessories.
Product CodeKOA
Regulation Number 876.4730
Device Class 1


Premarket Reviews
ManufacturerDecision
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1
FEMICARE-NIKOMED LTD
  SUBSTANTIALLY EQUIVALENT 1
VESITEC MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Shaft, split 1
Total Device Problems 1

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