FDA 510(k) Application Details - K202469

Device Classification Name	Colonoscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K202469
Device Name	Colonoscope And Accessories, Flexible/Rigid
Applicant	SMART Medical Systems Ltd. 5 HaNofar Street Raanana 4366404 IL Other 510(k) Applications for this Company
Contact	Adva Yoselzon Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FDF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/27/2020
Decision Date	10/26/2020
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