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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Barrier, Synthetic, Intraoral
510(k) Number K210797
Device Name Bio-MEM Ti Reinforced Membrane
Applicant
B&Medi Co., Ltd.
56-33, Chukhang-Daero 296beon-Gil, Jung-Gu
Incheon,  KR 22339
Applicant Contact Taesu Kwon
Correspondent
B&Medi Co., Ltd.
56-33, Chukhang-Daero 296beon-Gil, Jung-Gu
Incheon,  KR 22339
Correspondent Contact Taesu Kwon
Regulation Number872.3930
Classification Product Code
NPK  
Date Received03/16/2021
Decision Date 08/18/2022
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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