FDA 510(k) Application Details - K200684

Device Classification Name	More FDA Info for this Device
510(K) Number	K200684
Device Name	gastroduodenal FTRD Set
Applicant	Ovesco Endoscopy AG Friedrich-Miescher-StraBe 9 Tuebingen 72076 DE Other 510(k) Applications for this Company
Contact	Marc O. Schurr Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PKL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/16/2020
Decision Date	06/02/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review