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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, collagen, staple line reinforcement
510(k) Number K030879
Device Name VERITAS COLLAGEN MATRIX
Applicant
SYNOVIS SURGICAL INNOVATIONS
2575 UNIVERSITY AVE.
ST. PAUL,  MN  55114 -1024
Applicant Contact ANGELA MALLERY
Correspondent
SYNOVIS SURGICAL INNOVATIONS
2575 UNIVERSITY AVE.
ST. PAUL,  MN  55114 -1024
Correspondent Contact ANGELA MALLERY
Regulation Number878.3300
Classification Product Code
OXE  
Subsequent Product Codes
FTM   OWV   OXB   PAJ  
Date Received03/20/2003
Decision Date 04/24/2003
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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