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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 K060877
Device Name PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX
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 Received03/31/2006
Decision Date 04/27/2006
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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