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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 K171008
Device Name Anorganic Bone Mineral with Collagen in Delivery Applicator
Applicant
Collagen Matrix, Inc.
15 Thornton Road
Oakland,  NJ  07436
Applicant Contact Danielle Lindner
Correspondent
Collagen Matrix, Inc.
15 Thornton Road
Oakland,  NJ  07436
Correspondent Contact Danielle Lindner
Regulation Number872.3930
Classification Product Code
NPM  
Date Received04/04/2017
Decision Date 10/30/2017
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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