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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 K033314
Device Name PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM
Applicant
EV3 INC
4600 NATHAN LN. NORTH
PLYMOUTH,  MN  55442 -2920
Applicant Contact GLEN D SMYTHE
Correspondent
EV3 INC
4600 NATHAN LN. NORTH
PLYMOUTH,  MN  55442 -2920
Correspondent Contact GLEN D SMYTHE
Regulation Number876.5010
Classification Product Code
FGE  
Date Received10/15/2003
Decision Date 11/21/2003
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
Recalls CDRH Recalls
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