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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K180802
Device Name Meta P&Bond
Applicant
META BIOMED, CO., LTD.
270, Osong Saengmyeong 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 Number872.3200
Classification Product Code
KLE  
Date Received03/28/2018
Decision Date 08/29/2018
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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