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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 K173188
Device Name The Graft Natural Bone Substitute
Applicant
Purgo Biologics, Inc.
E-607, 700, Pangyo-Ro, Bundang-Gu
Seongnam-Si,  KR 13516
Applicant Contact Hana Jung
Correspondent
Purgo Biologics, Inc.
E-607, 700, Pangyo-Ro, Bundang-Gu
Seongnam-Si,  KR 13516
Correspondent Contact Hana Jung
Regulation Number872.3930
Classification Product Code
NPM  
Date Received10/02/2017
Decision Date 07/20/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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