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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 K200185
Device Name SYLFIRM X
Applicant
VIOL Co., Ltd.
C-808, 809, Bundang Technopark C, 744, Pangyo-Ro, Bundang-Gu
Seongnam-Si,  KR 13510
Applicant Contact Chai Kyoung Woo
Correspondent
VIOL Co., Ltd.
C-808, 809, Bundang Technopark C, 744, Pangyo-Ro, Bundang-Gu
Seongnam-Si,  KR 13510
Correspondent Contact Chai Kyoung Woo
Regulation Number878.4400
Classification Product Code
GEI  
Date Received01/24/2020
Decision Date 04/22/2020
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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