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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 K994068
Device Name S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
Applicant
Cordis Corp.
14201 NW 60th Ave.
Miami Lakes,  FL  33014
Applicant Contact ELENA JUGO
Correspondent
Cordis Corp.
14201 NW 60th Ave.
Miami Lakes,  FL  33014
Correspondent Contact ELENA JUGO
Regulation Number876.5010
Classification Product Code
FGE  
Date Received12/02/1999
Decision Date 12/23/1999
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
Predetermined Change
Control Plan Authorized		 No
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