FDA 510(k) Application Details - K080462

Device Classification Name Bone Grafting Material, Human Source

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510(K) Number K080462
Device Name Bone Grafting Material, Human Source
Applicant MEDTRONIC SOFAMOR DANEK
1800 PYRAMID PLACE
MEMPHIS, TN 38132 US
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Contact MICHELLE OBENAUER
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Regulation Number 872.3930

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Classification Product Code NUN
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Date Received 02/20/2008
Decision Date 05/13/2008
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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