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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 K991674
Device Name CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODELS PC155BJS, PCI156BJS, PC185BJS, PC186BJS
Applicant
CORDIS CORP.
40 TECHNOLOGY DR.
WARREN,  NJ  07059
Applicant Contact CHARLES J RYAN
Correspondent
CORDIS CORP.
40 TECHNOLOGY DR.
WARREN,  NJ  07059
Correspondent Contact CHARLES J RYAN
Regulation Number876.5010
Classification Product Code
FGE  
Date Received05/17/1999
Decision Date 08/12/1999
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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