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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 K010242
Device Name COOK ZILVER BILIARY STENT
Applicant
COOK, INC.
925 SOUTH CURRY PIKE
P.O. BOX 489
bloomington,  IN  47402
Applicant Contact lisa hopkins
Correspondent
COOK, INC.
925 SOUTH CURRY PIKE
P.O. BOX 489
bloomington,  IN  47402
Correspondent Contact lisa hopkins
Regulation Number876.5010
Classification Product Code
FGE  
Date Received01/25/2001
Decision Date 08/13/2001
Decision se - with limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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