FDA 510(k) Application Details - K210138

Device Classification Name	More FDA Info for this Device
510(K) Number	K210138
Device Name	iTind System
Applicant	Medi-Tate Ltd. 17 Hauman Street Hadera 3850169 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	01/19/2021
Decision Date	06/25/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review