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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 K062915
Device Name VERITAS COLLAGEN MATRIX
Applicant
SYNOVIS SURGICAL INNOVATIONS
2575 UNIVERSITY AVE.
ST. PAUL,  MN  55114 -1024
Applicant Contact CYNTHIA LAMARUCCIOLA
Correspondent
SYNOVIS SURGICAL INNOVATIONS
2575 UNIVERSITY AVE.
ST. PAUL,  MN  55114 -1024
Correspondent Contact CYNTHIA LAMARUCCIOLA
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Codes
OXB   OXE   PAJ  
Date Received09/27/2006
Decision Date 12/06/2006
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
Recalls CDRH Recalls
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