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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 K010411
Device Name PALMAZ GENESIS TRANSHEPATIC BILLARY STENT AND DELIVERY SYSTEM
Applicant
Cordis Corp.
7 Powderhorn Dr.
Warren,  NJ  07059
Applicant Contact CHARLES J RYAN
Correspondent
Cordis Corp.
7 Powderhorn Dr.
Warren,  NJ  07059
Correspondent Contact CHARLES J RYAN
Regulation Number876.5010
Classification Product Code
FGE  
Date Received02/12/2001
Decision Date 08/27/2001
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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