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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 K014007
Device Name DYNALINK .018 BILLARY SELF-EXPANDING STENT SYSTEM
Applicant
GUIDANT CORP.
3200 LAKESIDE DR.
SANTA CLARA,  CA  95054
Applicant Contact SABA MODJARRAD
Correspondent
GUIDANT CORP.
3200 LAKESIDE DR.
SANTA CLARA,  CA  95054
Correspondent Contact SABA MODJARRAD
Regulation Number876.5010
Classification Product Code
FGE  
Date Received12/05/2001
Decision Date 01/07/2002
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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