FDA 510(k) Application Details - K051188

Device Classification Name Bone Grafting Material, Human Source

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510(K) Number K051188
Device Name Bone Grafting Material, Human Source
Applicant OSTEOTECH, INC.
51 JAMES WAY
EATONTOWN, NJ 07724 US
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Contact CHRISTOPHER TALBOT
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Regulation Number 872.3930

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Classification Product Code NUN
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Date Received 05/10/2005
Decision Date 01/03/2006
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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