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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
510(k) Number K122306
Device Name SYNOVIS COLLAGEN MATRIX (TBD)
Applicant
Synovis Surgical Innovations
2575 University Ave.
West
St. Paul,  MN  55114
Applicant Contact JODI JORGENSON
Correspondent
Synovis Surgical Innovations
2575 University Ave.
West
St. Paul,  MN  55114
Correspondent Contact JODI JORGENSON
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received08/01/2012
Decision Date 03/08/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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