K-number	K162656
Device name	ESU-1 Electrosurgical Generator
Applicant	Tva Medical, Inc.
Product code	GEI
Device class	Class II
Decision date	Nov 10, 2016
Decision	Substantially Equivalent
Regulation	—

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View the full FDA submission: accessdata.fda.gov

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ESU-1 Electrosurgical Generator

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