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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 K130981
Device Name FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM; S.M.A.R.T. RE-FLEX BILIARY ELF-EXPANDING STENT SYSTEM
Applicant
CORDIS CORP.
6500 PASEO PADRE PARKWAY
FREMONT,  CA  94555
Applicant Contact KIM FONDA
Correspondent
CORDIS CORP.
6500 PASEO PADRE PARKWAY
FREMONT,  CA  94555
Correspondent Contact KIM FONDA
Regulation Number876.5010
Classification Product Code
FGE  
Date Received04/09/2013
Decision Date 03/12/2014
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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