FDA 510(k) Application Details - K112572

Device Classification Name Bone Grafting Material, Animal Source

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510(K) Number K112572
Device Name Bone Grafting Material, Animal Source
Applicant GEISTLICH PHARMA AG
555 TWELFTH STREET, NW
WASHINGTON, DC 20004-1206 US
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Contact DANIEL A KRACOV
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Regulation Number 872.3930

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Classification Product Code NPM
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Date Received 09/06/2011
Decision Date 12/28/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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