FDA 510(k) Application Details - K072397

Device Classification Name Bone Grafting Material, Synthetic

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510(K) Number K072397
Device Name Bone Grafting Material, Synthetic
Applicant COLLAGEN MATRIX, INC.
509 COMMERCE ST.
FRANKLIN LAKES, NJ 07417 US
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Contact PEGGY HANSEN
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Regulation Number 872.3930

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Classification Product Code LYC
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Date Received 08/27/2007
Decision Date 10/18/2007
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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