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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Nephrostomy
510(k) Number K920509
Device Name URESIL SUMP DRAINAGE CATHETER
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
Classification Product Code
LJE  
Date Received02/04/1992
Decision Date 09/14/1992
Decision Substantially Equivalent (SESE)
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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