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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 K032206
Device Name PARAMOUNT MINI STENT AND DELIVERY SYSTEM BILIARY INDICATION
Applicant
EV3 INC
4600 NATHAN LN. NORTH
PLYMOUTH,  MN  55442
Applicant Contact GLEN D SMYTHE
Correspondent
EV3 INC
4600 NATHAN LN. NORTH
PLYMOUTH,  MN  55442
Correspondent Contact GLEN D SMYTHE
Regulation Number876.5010
Classification Product Code
FGE  
Date Received07/18/2003
Decision Date 08/08/2003
Decision Substantially Equivalent (SESE)
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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