FDA 510(k) Application Details - K051443

Device Classification Name Bone Grafting Material, Synthetic

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510(K) Number K051443
Device Name Bone Grafting Material, Synthetic
Applicant CURASAN AG, FRANKFURT FACILITY
109 SHORE DRIVE
GARNER, NC 27529 US
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Contact ERIC WIECHERT
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Regulation Number 872.3930

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Classification Product Code LYC
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Date Received 06/02/2005
Decision Date 07/22/2005
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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