FDA 510(k) Application Details - DEN160014

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN160014
Device Name	remOVE System
Applicant	OVESCO ENDOSCOPY AG DORFACKERSTRASSE 26 TUEBINGEN, 72074 DE Other 510(k) Applications for this Company
Contact	Med.Marc O. Schurr Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QAG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/11/2016
Decision Date	12/22/2017
Decision	DENG -
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review