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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name biliary catheter for stone removal that may also allow for irrigation and contrast injection
510(k) Number K915343
Device Name URESIL LAPAROSCOPIC CHOLANGIOGRAPHY 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
Regulation Number876.5010
Classification Product Code
GCA  
Date Received11/26/1991
Decision Date 03/31/1992
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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