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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 K011881
Device Name DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM
Applicant
Guidant Corp.
26531 Ynez Rd.
Temecula,  CA  92591 -4630
Applicant Contact SABA MODJARRAD
Correspondent
Guidant Corp.
26531 Ynez Rd.
Temecula,  CA  92591 -4630
Correspondent Contact SABA MODJARRAD
Regulation Number876.5010
Classification Product Code
FGE  
Date Received06/18/2001
Decision Date 07/18/2001
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
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