FDA 510(k) Application Details - K960368

Device Classification Name Bone Grafting Material, Synthetic

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510(K) Number K960368
Device Name Bone Grafting Material, Synthetic
Applicant CERAMED CORP.
12860 WEST CEDAR DR., STE. 110
LAKEWOOD, CO 80228 US
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Contact BARBARA A WATSON
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Regulation Number 872.3930

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Classification Product Code LYC
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Date Received 01/25/1996
Decision Date 04/18/1996
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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