FDA 510(k) Application Details - K023998

Device Classification Name Bone Grafting Material, Synthetic

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510(K) Number K023998
Device Name Bone Grafting Material, Synthetic
Applicant THERICS, INC.
115 CAMPUS DR.
PRINCETON, NJ 08540 US
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Contact UMBERTO V PARROTTA
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Regulation Number 872.3930

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Classification Product Code LYC
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Date Received 12/03/2002
Decision Date 03/26/2003
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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