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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device electrosurgical vessel and/or tissue sealer. with built-in generator.
Regulation Description Electrosurgical cutting and coagulation device and accessories.
Definition Intended for any procedure where vessel ligation (cutting and sealing), soft tissue grasping and dissection are performed.
Product CodePDG
Regulation Number 878.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
ETHICON
  SUBSTANTIALLY EQUIVALENT 1

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