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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
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