FDA 510(k) Application Details - K103709

Device Classification Name Bone Grafting Material, For Dental Bone Repair

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510(K) Number K103709
Device Name Bone Grafting Material, For Dental Bone Repair
Applicant CURASAN AG
PIAZZA ALBANIA, 10
ROME 00153 IT
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Contact ROGER GRAY
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Regulation Number 872.3930

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Classification Product Code LPK
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Date Received 12/20/2010
Decision Date 03/10/2011
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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