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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Urological
510(k) Number K180354
Device Name UroGen Ureteral Catheter
Applicant
Urogen Pharma, Ltd.
9 Ha`Ta`Asiya St.
Ra’Anana,  IL 4365007
Applicant Contact James G. Ottinger
Correspondent
Urogen Pharma
499 Park Ave., 12th Floor, Suite 1200
New York,  NY  10022
Correspondent Contact James G. Ottinger
Regulation Number876.5130
Classification Product Code
KOD  
Date Received02/08/2018
Decision Date 10/30/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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