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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device coagulator, laparoscopic, unipolar (and accessories)
Regulation Description Unipolar endoscopic coagulator-cutter and accessories.
Product CodeHFG
Regulation Number 884.4160
Device Class 2


Premarket Reviews
ManufacturerDecision
ASPEN LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
HALT MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Material separation 6
Other (for use when an appropriate device code cannot be identified) 1
No Known Device Problem 1
No display or display failure 1
Loss of power 1
Total Device Problems 10

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