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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 K921191
Device Name GIANTURCO-ROSCH BILIARY Z STENT
Applicant
COOK, INC.
925 SOUTH CURRY PIKE
P.O. BOX 489
BLOOMINGTON,  IN  47402
Applicant Contact APRIL LAVENDER
Correspondent
COOK, INC.
925 SOUTH CURRY PIKE
P.O. BOX 489
BLOOMINGTON,  IN  47402
Correspondent Contact APRIL LAVENDER
Regulation Number876.5010
Classification Product Code
FGE  
Date Received02/27/1992
Decision Date 05/15/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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