FDA 510(k) Application Details - K123013

Device Classification Name	Endoscopic Access Overtube, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K123013
Device Name	Endoscopic Access Overtube, Gastroenterology-Urology
Applicant	NOVADAQ TECHNOLOGIES, INC. 13155 DELF PLACE, UNIT 250 RICHMOND, BRITISH COLUMBIA V6V 2A2 CA Other 510(k) Applications for this Company
Contact	TIM VERSPAGEN Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FED Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2012
Decision Date	03/22/2013
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