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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K212500
Device Name ArtiSential Trocar
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 Number876.1500
Classification Product Code
GCJ  
Date Received08/09/2021
Decision Date 12/03/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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