FDA 510(k) Application Details - K051091

Device Classification Name Bone Grafting Material, Synthetic

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510(K) Number K051091
Device Name Bone Grafting Material, Synthetic
Applicant BICON, INC.
501 ARBORWAY
BOSTON, MA 02130 US
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Contact VINCENT J MORGAN
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Regulation Number 872.3930

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Classification Product Code LYC
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Date Received 04/28/2005
Decision Date 09/01/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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