FDA 510(k) Application Details - K092567

Device Classification Name Bone Grafting Material, Synthetic

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510(K) Number K092567
Device Name Bone Grafting Material, Synthetic
Applicant UNICARE BIOMEDICAL, INC.
22971-B TRITON WAY
LAGUNA HILLS, CA 92653 US
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Contact STAN YANG
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Regulation Number 872.3930

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Classification Product Code LYC
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Date Received 08/20/2009
Decision Date 11/25/2009
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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