FDA 510(k) Application Details - K133076

Device Classification Name	Endoscopic Guidewire, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K133076
Device Name	Endoscopic Guidewire, Gastroenterology-Urology
Applicant	NEOMETRICS, INC. 2605 FERNBROOK LANE N. SUITE J PLYMOUTH, MN 55447 US Other 510(k) Applications for this Company
Contact	DAVID LIEBL Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	OCY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2013
Decision Date	02/20/2014
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