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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name skin resurfacing rf applicator
510(k) Number K150409
Device Name VIVACE Electrosurgical System
Applicant
Sung Hwan E&B Co.,Ltd
SK Techno Bld Suite #502 ,16-4 Seongsu-Dong 1-Ga
Seongdong-Gu,  KR 133710
Applicant Contact Sun Young Kang
Correspondent
510K Technology Group, LLC
263 Huntington Avenue, Suite #332
Boston,  MA  02115
Correspondent Contact Kachi Enyinna
Regulation Number878.4400
Classification Product Code
OUH  
Date Received02/18/2015
Decision Date 01/15/2016
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
Recalls CDRH Recalls
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