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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 K032768
Device Name MEDTRONIC, INC. RACER BILIARY STENT SYSTEM (RACER), MODEL XD#YF(L)
Applicant
Medtronic Ave, Inc.
3576 Unocal Place
Santa Rosa,  CA  95403
Applicant Contact SARAH SHEPHARD
Correspondent
Medtronic Ave, Inc.
3576 Unocal Place
Santa Rosa,  CA  95403
Correspondent Contact SARAH SHEPHARD
Regulation Number876.5010
Classification Product Code
FGE  
Date Received09/08/2003
Decision Date 10/09/2003
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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