FDA 510(k) Application Details - K111105

Device Classification Name Bone Grafting Material, Synthetic

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510(K) Number K111105
Device Name Bone Grafting Material, Synthetic
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 LYC
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Date Received 04/20/2011
Decision Date 12/20/2012
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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