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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 K162158
Device Name Porcine Anorganic Bone Mineral in Delivery Applicator
Applicant
Collagen Matrix, Inc.
15 Thornton Rd.
Oakland,  NJ  07436
Applicant Contact Peggy Hansen
Correspondent
Collagen Matrix, Inc.
15 Thornton Rd.
Oakland,  NJ  07436
Correspondent Contact Peggy Hansen
Regulation Number872.3930
Classification Product Code
NPM  
Date Received08/02/2016
Decision Date 02/09/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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