FDA 510(k) Application Details - K160861

Device Classification Name	Endoscopic Access Overtube, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K160861
Device Name	Endoscopic Access Overtube, Gastroenterology-Urology
Applicant	C.R. Bard, Inc. 8195 Industrial Blvd Covington, GA 30014 US Other 510(k) Applications for this Company
Contact	Beatrice Wan 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	03/29/2016
Decision Date	03/31/2016
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	Y
Expedited Review