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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
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