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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 K003753
Device Name GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL, GP GENERAL PURPOSE DRAINAGE CATHE
Applicant
URESIL CORP.
5418 W. TOUHY AVE.
SKOKIE,  IL  60077
Applicant Contact CHARLES P GILL
Correspondent
URESIL CORP.
5418 W. TOUHY AVE.
SKOKIE,  IL  60077
Correspondent Contact CHARLES P GILL
Regulation Number876.5010
Classification Product Code
FGE  
Subsequent Product Codes
GBO   GBX   LJE  
Date Received12/05/2000
Decision Date 01/04/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Special
Reviewed by Third Party No
Combination Product No
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