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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Grafting Material, Animal Source
510(k) Number K191737
Device Name The Graft Bone Substitute
Applicant
Purgo Biologics Inc.
E-607, 700, Pangyo-ro
Bundang-gu
Seongnam-si,  KR 13516
Applicant Contact Eun Ho Kim
Correspondent
Purgo Biologics Inc.
E-607, 700, Pangyo-ro
Bundang-gu
Seongnam-si,  KR 13516
Correspondent Contact Eun Ho Kim
Regulation Number872.3930
Classification Product Code
NPM  
Date Received06/28/2019
Decision Date 02/14/2020
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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