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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name powder, porcelain
510(k) Number K191902
Device Name Razor, Everest, U&C Liquid
Applicant
U&C International Co., Ltd.
RM 1F/2F, 13, Digital-ro 27-gil, Guro-gu
seoul,  KR
Applicant Contact jong-min kim
Correspondent
LK Consulting Group USA, Inc.
1150 Roosevelt, STE 200
irvine,  CA  92620
Correspondent Contact priscilla chung
Regulation Number872.6660
Classification Product Code
EIH  
Date Received07/16/2019
Decision Date 10/11/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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