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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 K011039
Device Name OMNILINK .018 BILIARY STENT SYSTEM
Applicant
GUIDANT CORP.
3200 LAKESIDE DR.
SANTA CLARA,  CA  95054 -2807
Applicant Contact CURTIS TRUESDALE
Correspondent
GUIDANT CORP.
3200 LAKESIDE DR.
SANTA CLARA,  CA  95054 -2807
Correspondent Contact CURTIS TRUESDALE
Regulation Number876.5010
Classification Product Code
FGE  
Date Received04/05/2001
Decision Date 05/08/2001
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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