FDA 510(k) Application Details - K053374

Device Classification Name Bone Grafting Material, Synthetic

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510(K) Number K053374
Device Name Bone Grafting Material, Synthetic
Applicant OSSACUR AG
975 VERONICS SPRINGS ROAD
SANTA BARBARA, CA 93105 US
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Contact KRISTI KISTNER
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Regulation Number 872.3930

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Classification Product Code LYC
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Date Received 12/05/2005
Decision Date 02/21/2006
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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