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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. WEST
ST. PAUL,  MN  55114 -1024
Applicant Contact ANGELA MALLERY
Correspondent
SYNOVIS SURGICAL INNOVATIONS
2575 UNIVERSITY AVE. WEST
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
Recalls CDRH Recalls
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