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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 K990631
Device Name CORDIA PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODEL PC125BPS, PC126BPS, PC127BPS,PC128BPS, PC
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 Received02/26/1999
Decision Date 04/30/1999
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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