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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Crown And Bridge, Temporary, Resin
510(k) Number K190724
Device Name MD-Temp Plus
Applicant
Meta Biomed Co., Ltd.
270 Osongsaengmyeong 1-Ro, Osong-Eup, Heungdeok-Gu
Cheongju-Si,  KR 28161
Applicant Contact Suk Song Oh
Correspondent
Withus Group, Inc.
106 Superior
Irvine,  CA  92620
Correspondent Contact April Lee
Regulation Number872.3770
Classification Product Code
EBG  
Date Received03/20/2019
Decision Date 07/03/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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