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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 K972583
Device Name URESIL GENERAL PURPOSE DRAINAGE CATHETER, URESIL NEPHROSTOMY CATHETER, URESIL BILIARY CATHETER, URESIL NEPHRO-URETERAL S
Applicant
URESIL CORP.
5418 W. TOUHY AVE.
SKOKIE,  IL  60077
Applicant Contact LEV MELINYSHYN
Correspondent
URESIL CORP.
5418 W. TOUHY AVE.
SKOKIE,  IL  60077
Correspondent Contact LEV MELINYSHYN
Regulation Number876.5010
Classification Product Code
FGE  
Subsequent Product Codes
GBO   GBX  
Date Received07/10/1997
Decision Date 08/29/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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