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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 K061566
Device Name PRIMUS GPS BILIARY STENT SYSTEM
Applicant
EV3 INC
9600 54TH AVENUE NORTH
PLYMOUTH,  MN  55442 -2920
Applicant Contact MELISSA SOMMERFELD
Correspondent
EV3 INC
9600 54TH AVENUE NORTH
PLYMOUTH,  MN  55442 -2920
Correspondent Contact MELISSA SOMMERFELD
Regulation Number876.5010
Classification Product Code
FGE  
Date Received06/06/2006
Decision Date 08/31/2006
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
Recalls CDRH Recalls
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