FDA 510(k) Application Details - K032673

Device Classification Name Mesh, Surgical, Polymeric

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510(K) Number K032673
Device Name Mesh, Surgical, Polymeric
Applicant OSTEOBIOLOGICS, INC.
UNIVERSITY BUSINESS PARK
12500 NETWORK, SUITE 112
SAN ANTONIO, TX 78249-3308 US
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Contact GABRIELE G NIEDERAUER
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Regulation Number 878.3300

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Classification Product Code FTL
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Date Received 08/29/2003
Decision Date 10/02/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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