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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 K903449
Device Name URESIL TRU-CLOSE MULTI-PURPOSE DRAINAGE SET
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 Received07/30/1990
Decision Date 09/12/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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