FDA 510(k) Application Details - K162205

Device Classification Name	Endoscopic Access Overtube, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K162205
Device Name	Endoscopic Access Overtube, Gastroenterology-Urology
Applicant	BODDINGTONS PLASTICS LTD UNIT 6 PATTENDEN LANE, MARDEN TONBRIDGE TN12 9QJ GB Other 510(k) Applications for this Company
Contact	SARAH GIBSON 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	08/05/2016
Decision Date	12/09/2016
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	N
Expedited Review