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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 K200875
Device Name ArtiSential Laparoscopic Instruments - Electrodes
Applicant
Livsmed, Inc.
304, D-Dong, 700, Pangyo-Ro, Bundang-Gu
Seongnam-Si,  KR 13516
Applicant Contact Dong Wook Lee
Correspondent
Livsmed, Inc.
304, D-Dong, 700, Pangyo-Ro, Bundang-Gu
Seongnam-Si,  KR 13516
Correspondent Contact Dong Wook Lee
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/01/2020
Decision Date 06/17/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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