FDA 510(k) Application Details - K091142

Device Classification Name Mesh, Surgical

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510(K) Number K091142
Device Name Mesh, Surgical
Applicant RTI BIOLOGICS, INC.
11621 RESEARCH CIRCLE
P.O. BOX 2650
ALACHUA, FL 32616-1627 US
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Contact TRAVIS AROLA
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Regulation Number 878.3300

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Classification Product Code FTM
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Date Received 04/20/2009
Decision Date 08/31/2009
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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