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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K162656
Device Name ESU-1 Electrosurgical Generator
Applicant
Tva Medical, Inc.
7000 Bee Caves Rd., Suite 250
Austin,  TX  78746
Applicant Contact Katherine Kumar
Correspondent
Tva Medical, Inc.
7000 Bee Caves Rd., Suite 250
Austin,  TX  78746
Correspondent Contact Katherine Kumar
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/23/2016
Decision Date 11/10/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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