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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device unit, electrosurgical, endoscopic (with or without accessories), reprocessed
Regulation Description Endoscopic electrosurgical unit and accessories.
Definition This device is intended to be used endoscopically to remove tissue and control bleeding by use of high frequency electrical current. This device is indicated for reuse/reprocessing.
Product CodeNLR
Regulation Number 876.4300
Device Class 2


Premarket Reviews
ManufacturerDecision
MEDISISS
  SUBSTANTIALLY EQUIVALENT 1

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