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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 K120152
Device Name CERASORB PLUS
Applicant
Riemser Arzneimittel AG
5105 Fairoaks Rd.
Durham,  NC  27712
Applicant Contact James M Clinton
Correspondent
Riemser Arzneimittel AG
5105 Fairoaks Rd.
Durham,  NC  27712
Correspondent Contact James M Clinton
Regulation Number872.3930
Classification Product Code
NPM  
Date Received01/18/2012
Decision Date 08/13/2012
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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