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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 K040667
Device Name XPERT BILIARY STENT, MODELS EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006, EX8S3008, EX8S4008, EX8S6008
Applicant
ABBOTT LABORATORIES
400 SAGINAW DR.
REDWOOD CITY,  CA  94063
Applicant Contact JOANNA KUSKOWSKI
Correspondent
ABBOTT LABORATORIES
400 SAGINAW DR.
REDWOOD CITY,  CA  94063
Correspondent Contact JOANNA KUSKOWSKI
Regulation Number876.5010
Classification Product Code
FGE  
Date Received03/15/2004
Decision Date 04/07/2004
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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