FDA 510(k) Application Details - K041669

Device Classification Name Mesh, Surgical

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510(K) Number K041669
Device Name Mesh, Surgical
Applicant SYNOVIS SURGICAL INNOVATIONS
2575 UNIVERSITY AVE. WEST
ST. PAUL, MN 55114-1024 US
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Contact JAMES JENKINS
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Regulation Number 878.3300

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Classification Product Code FTM
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Date Received 06/21/2004
Decision Date 10/27/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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