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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 K190909
Device Name ArtiSential Bipolar Fenestrated Forceps
Applicant
Livsmed Inc.
#304, D-dong, 700, Pangyo-ro, Bundang-gu
Seongnam-si,  KR 13516
Applicant Contact Dong Wook Lee
Correspondent
BT Solutions, Inc.
Unit 904, Eonju-ro 86-gil 5
Seoul,  KR 06210
Correspondent Contact Do Hyun Kim
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/08/2019
Decision Date 02/13/2020
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
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