FDA 510(k) Application Details - K203321

Device Classification Name	More FDA Info for this Device
510(K) Number	K203321
Device Name	Cystoject Syringe Lever
Applicant	UroGen Pharma Ltd 9 Ha'Ta'asiya Street Ra'anana 4365405 IL Other 510(k) Applications for this Company
Contact	James G. Ottinger 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	11/12/2020
Decision Date	12/09/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review