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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device unit, cautery, thermal, ac-powered
Regulation Description Thermal cautery unit.
Product CodeHQO
Regulation Number 886.4115
Device Class 2


Premarket Reviews
ManufacturerDecision
SPEMBLY CRYOSURGERY
  SUBSTANTIALLY EQUIVALENT 1
STARION INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Failure to deliver energy 3
Loss of power 1
Smoking 1
Cable, defective 1
Total Device Problems 6

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