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FDA 510(k) Application Details - K032673
Device Classification Name
Mesh, Surgical, Polymeric
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
878.3300
More FDA Info for this Regulation Number
Classification Product Code
FTL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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