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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stents, Drains And Dilators For The Biliary Ducts
510(k) Number K032436
Device Name DURAMAX .018 BILIARY STENT SYSTEM
Applicant
Avantec Vascular Corp.
1049 Kiel Ct.
Sunnyvale,  CA  94089
Applicant Contact JAMES M SHY
Correspondent
Avantec Vascular Corp.
1049 Kiel Ct.
Sunnyvale,  CA  94089
Correspondent Contact JAMES M SHY
Regulation Number876.5010
Classification Product Code
FGE  
Date Received08/07/2003
Decision Date 02/04/2004
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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