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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 K062798
Device Name SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB
Applicant
CORDIS CORP.
7 POWDER HORN DRIVE
WARREN,  NJ  07059
Applicant Contact KAREN WILK
Correspondent
CORDIS CORP.
7 POWDER HORN DRIVE
WARREN,  NJ  07059
Correspondent Contact KAREN WILK
Regulation Number876.5010
Classification Product Code
FGE  
Date Received09/19/2006
Decision Date 02/06/2008
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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