FDA 510(k) Application Details - K180345

Device Classification Name	More FDA Info for this Device
510(K) Number	K180345
Device Name	Uroject12 Syringe Lever
Applicant	UroGen Pharma Ltd. 9 Ha`Ta`asiya Street RaÆanana 4365007 IL Other 510(k) Applications for this Company
Contact	Liz Schindel Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QBL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/08/2018
Decision Date	10/17/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review