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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 K053245
Device Name GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIG DRAINAGE CATHETER; NEPHROSTOMY CATHETER; BILIARY CATHETER
Applicant
Uresil, LLC
5418 W. Touhy Ave.
Skokie,  IL  60077
Applicant Contact MATTHEW MAHON
Correspondent
Uresil, LLC
5418 W. Touhy Ave.
Skokie,  IL  60077
Correspondent Contact MATTHEW MAHON
Regulation Number876.5010
Classification Product Code
FGE  
Subsequent Product Codes
GBO   GBX   LJE  
Date Received11/21/2005
Decision Date 12/20/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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