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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 K052539
Device Name COOK FORMULA 418 BILIARY STENT SYSTEM
Applicant
COOK, INC.
750 DANIELS WAY
P.O. BOX 489
BLOOMINGTON,  IN  47402
Applicant Contact KAREN BRADBURN
Correspondent
COOK, INC.
750 DANIELS WAY
P.O. BOX 489
BLOOMINGTON,  IN  47402
Correspondent Contact KAREN BRADBURN
Regulation Number876.5010
Classification Product Code
FGE  
Date Received09/15/2005
Decision Date 12/09/2005
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
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