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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
Predetermined Change
Control Plan Authorized		 No
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