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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 K050698
Device Name MODIFICATION TO:ZILVER 518 BILIARY STENT
Applicant
COOK, INC.
750 DANIELS WAY
P.O. BOX 489
BLOOMINGTON,  IN  47402
Applicant Contact STEPHANIE ROBERTS
Correspondent
COOK, INC.
750 DANIELS WAY
P.O. BOX 489
BLOOMINGTON,  IN  47402
Correspondent Contact STEPHANIE ROBERTS
Regulation Number876.5010
Classification Product Code
FGE  
Date Received03/17/2005
Decision Date 03/30/2005
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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