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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrosurgical, Active, Urological
510(k) Number K163090
Device Name Plasma Edge System
Applicant
Chirurgie Innovation
27 PLACE VICTOR SCHOELCHER
MASSY,  FR F-91300
Applicant Contact Guillaume Noury
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number876.4300
Classification Product Code
FAS  
Subsequent Product Codes
FDC   GEI  
Date Received11/04/2016
Decision Date 05/23/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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