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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Piston Syringe Lever
510(k) Number K180345
Device Name Uroject12 Syringe Lever
Applicant
Urogen Pharma, Ltd.
9 Ha`Ta`Asiya St.
Ra’Anana,  IL 4365007
Applicant Contact Liz Schindel
Correspondent
Urogen Pharma, Ltd.
499 Park Ave., 12th Floor, Suite 1200
New York,  NY  10022
Correspondent Contact James G Ottinger
Regulation Number880.5860
Classification Product Code
QBL  
Date Received02/08/2018
Decision Date 10/17/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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