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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 K040653
Device Name PARAMOUNT MINI GPS BILIARY STENT SYSTEM
Applicant
EV3 INC
4600 NATHAN LN. NORTH
PLYMOUTH,  MN  55442 -2920
Applicant Contact MARIA E BRITTLE
Correspondent
EV3 INC
4600 NATHAN LN. NORTH
PLYMOUTH,  MN  55442 -2920
Correspondent Contact MARIA E BRITTLE
Regulation Number876.5010
Classification Product Code
FGE  
Date Received03/12/2004
Decision Date 04/28/2004
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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