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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 K040415
Device Name PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT
Applicant
Synovis Surgical Innovations
2575 University Ave. W.
St. Paul,  MN  55114 -1024
Applicant Contact ANGELA MALLERY
Correspondent
Synovis Surgical Innovations
2575 University Ave. W.
St. Paul,  MN  55114 -1024
Correspondent Contact ANGELA MALLERY
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received02/18/2004
Decision Date 04/14/2004
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
Recalls CDRH Recalls
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