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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 K030839
Device Name MEDTRONIC AVE BRIDGE AURORA BILIARY STENT SYSTEM (AURORA)
Applicant
MEDTRONIC AVE, INC.
3576 Unocal Place
Santa Rosa,  CA  95403
Applicant Contact MARLENE COBB-CARLSON
Correspondent
MEDTRONIC AVE, INC.
3576 Unocal Place
Santa Rosa,  CA  95403
Correspondent Contact MARLENE COBB-CARLSON
Regulation Number876.5010
Classification Product Code
FGE  
Date Received03/17/2003
Decision Date 05/30/2003
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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