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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
Original Applicant
RIEMSER ARZNEIMITTEL AG
5105 fairoaks rd.
durham,  NC  27712
Original 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
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