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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 K190987
Device Name Uroject12 Syringe Lever
Applicant
UroGen Pharma Ltd.
9 Ha`Ta`asiya Street
Ra’anana,  IL 4365405
Applicant Contact Liz Schindel
Correspondent
UroGen Pharma Inc
499 Park Avenue, 12th Floor, Suite 1200
New York,  NY  10022
Correspondent Contact James G. Ottinger
Regulation Number880.5860
Classification Product Code
QBL  
Date Received04/15/2019
Decision Date 12/02/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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