FDA 510(k) Application Details - DEN190020

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN190020
Device Name	iTind System
Applicant	Medi-Tate Ltd. 14 Hailan Street Or Akiva 3060000 IL Other 510(k) Applications for this Company
Contact	Lihi Liviatan Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QKA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/02/2019
Decision Date	02/25/2020
Decision	DENG -
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review