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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 K192545
Device Name Potenza
Applicant
Jeisys Medical Incorporated
307 Daeyung Techno Town 8th; Gamasan-Ro 96, Geumcheon-Gu
Seoul,  KR 08501
Applicant Contact Wonchel Choi
Correspondent
Iqvia
18 Bridie Lane
Norfolk,  MA  02056
Correspondent Contact Pamela J Weagraff
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
OUH  
Date Received09/16/2019
Decision Date 02/20/2020
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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