FDA 510(k) Application Details - K140295

Device Classification Name	Gastroscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K140295
Device Name	Gastroscope And Accessories, Flexible/Rigid
Applicant	GI SCIENTIFIC LLC 128 Blye HIll Landing Newbury, NH 03255 US Other 510(k) Applications for this Company
Contact	MICHELE LUCEY Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FDS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/06/2014
Decision Date	07/24/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review