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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Bag, Bile Collecting
510(k) Number K901844
Device Name URESIL TRU-CLOSE DRAINAGE BAG
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
EXF  
Date Received04/24/1990
Decision Date 06/01/1990
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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