FDA 510(k) Application Details - K150083

Device Classification Name	Endoscopic Access Overtube, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K150083
Device Name	Endoscopic Access Overtube, Gastroenterology-Urology
Applicant	C2 THERAPEUTICS 303 CONVENTION WAY SUITE 1 REDWOOD CITY, CA 94063 US Other 510(k) Applications for this Company
Contact	THERESA BRANDNER-ALLEN 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	01/15/2015
Decision Date	04/14/2015
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