FDA 510(k) Application Details - K120152

Device Classification Name Bone Grafting Material, Animal Source

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510(K) Number K120152
Device Name Bone Grafting Material, Animal Source
Applicant RIEMSER ARZNEIMITTEL AG
5105 FAIROAKS RD.
DURHAM, NC 27712 US
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Contact James M Clinton
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Regulation Number 872.3930

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Classification Product Code NPM
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Date Received 01/18/2012
Decision Date 08/13/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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