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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Barrier, Animal Source, Intraoral
510(k) Number K200623
Device Name OssGuide
Applicant
Sk Bioland Co., Ltd.
162, Gwahaksaneop 3-Ro, Ochang-Eup, Cheongwon-Gu
Cheongju-Si,  KR 28125
Applicant Contact Yeonjeong Chae
Correspondent
Wise Company, Inc.
Rm.#303, The Sky Balley-303, 142, Gasan Digital 1-Ro
Geumcheon-Gu,  KR 08507
Correspondent Contact Sanglok Lee
Regulation Number872.3930
Classification Product Code
NPL  
Date Received03/09/2020
Decision Date 10/02/2020
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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