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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 K040119
Device Name PERI-STRIPS STAPLE LINE REINFORCEMENT-SLEEVE CONFIGURATION, PERI-STRIPS STAPLE LINE REINFORCEMENT-STRIP CONFIGURATION
Applicant
SYNOVIS SURGICAL INNOVATIONS
2575 UNIVERSITY AVE.
ST. PAUL,  MN  55114 -1024
Applicant Contact ANGELA MALLERY
Correspondent
SYNOVIS SURGICAL INNOVATIONS
2575 UNIVERSITY AVE.
ST. PAUL,  MN  55114 -1024
Correspondent Contact ANGELA MALLERY
Regulation Number878.3300
Classification Product Code
FTM  
Date Received01/20/2004
Decision Date 03/17/2004
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
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