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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 K201859
Device Name Porcine Mineral Collagen Composite Moldable
Applicant
Collagen Matrix, Inc.
15 Thornton Road
Oakland,  NJ  07436
Applicant Contact Gloria Zuclich
Correspondent
Collagen Matrix, Inc.
15 Thornton Road
Oakland,  NJ  07436
Correspondent Contact Gloria Zuclich
Regulation Number872.3930
Classification Product Code
NPM  
Date Received07/06/2020
Decision Date 09/11/2020
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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