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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 K041796
Device Name PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
Applicant
CORDIS CORPORATION
14201 N.W. 60TH AVENUE
MIAMI LAKES,  FL  33014
Applicant Contact ELENA S JUGO
Correspondent
CORDIS CORPORATION
14201 N.W. 60TH AVENUE
MIAMI LAKES,  FL  33014
Correspondent Contact ELENA S JUGO
Regulation Number876.5010
Classification Product Code
FGE  
Date Received07/02/2004
Decision Date 08/03/2004
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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