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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 K033393
Device Name ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM
Applicant
GUIDANT CORP.
3200 LAKESIDE DR.
SANTA CLARA,  CA  95054
Applicant Contact KELLY PIKE
Correspondent
GUIDANT CORP.
3200 LAKESIDE DR.
SANTA CLARA,  CA  95054
Correspondent Contact KELLY PIKE
Regulation Number876.5010
Classification Product Code
FGE  
Date Received10/23/2003
Decision Date 11/10/2003
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
Recalls CDRH Recalls
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