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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 K021345
Device Name MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
Applicant
CORDIS CORP.
7 POWDER HORN DR.
WARREN,  NJ  07059
Applicant Contact KAREN WILK
Correspondent
CORDIS CORP.
7 POWDER HORN DR.
WARREN,  NJ  07059
Correspondent Contact KAREN WILK
Regulation Number876.5010
Classification Product Code
FGE  
Date Received04/29/2002
Decision Date 06/28/2002
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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