FDA 510(k) Application Details - K142068

Device Classification Name	Endoscopic Irrigation/Suction System   More FDA Info for this Device
510(K) Number	K142068
Device Name	Endoscopic Irrigation/Suction System
Applicant	MEDOVATIONS, INC. 102 EAST KEEFE AVE. MILWAUKEE, WI 53212 US Other 510(k) Applications for this Company
Contact	LAURA BOLL Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	OCX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/30/2014
Decision Date	03/10/2015
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