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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 K041669
Device Name VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD
Applicant
SYNOVIS SURGICAL INNOVATIONS
2575 UNIVERSITY AVE. WEST
ST. PAUL,  MN  55114 -1024
Applicant Contact JAMES JENKINS
Correspondent
SYNOVIS SURGICAL INNOVATIONS
2575 UNIVERSITY AVE. WEST
ST. PAUL,  MN  55114 -1024
Correspondent Contact JAMES JENKINS
Regulation Number878.3300
Classification Product Code
FTM  
Date Received06/21/2004
Decision Date 10/27/2004
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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