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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 K231287
Device Name POTENZA
Applicant
Jeisys Medical, Inc.
307 Daeryung Techno Town 8th
Seoul,  KR 08501
Applicant Contact Bora Kim
Correspondent
Jeisys Medical Incorporated
307 Daeyung Techno Town 8th
Anyang-Si,  KR 14067
Correspondent Contact Sanghwa Myung
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/04/2023
Decision Date 11/05/2024
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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