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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
Original Applicant
SYNOVIS SURGICAL INNOVATIONS
2575 university ave.
st. paul,  MN  55114 1024
Original 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 (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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