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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical
510(k) Number K083039
Device Name VERITAS COLLAGEN MATRIX (DRY)
Applicant
SYNOVIS SURGICAL INNOVATIONS
2575 UNIVERSITY AVE. WEST
ST. PAUL,  MN  55114 -1024
Applicant Contact JODI JORGENSON
Correspondent
SYNOVIS SURGICAL INNOVATIONS
2575 UNIVERSITY AVE. WEST
ST. PAUL,  MN  55114 -1024
Correspondent Contact JODI JORGENSON
Regulation Number878.3300
Classification Product Code
FTM  
Date Received10/14/2008
Decision Date 11/26/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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