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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 K983075
Device Name GUIDANT MEGALINK BILIARY STENT, MODEL #'S 1002949-18, 1002949-28, 1002949-38
Applicant
Guidant Corp.
3200 Lakeside Dr.
Santa Clara,  CA  95054
Applicant Contact SANDRA SUNDELL
Correspondent
Guidant Corp.
3200 Lakeside Dr.
Santa Clara,  CA  95054
Correspondent Contact SANDRA SUNDELL
Regulation Number876.5010
Classification Product Code
FGE  
Date Received09/02/1998
Decision Date 03/03/1999
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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