FDA 510(k) Application Details - K152182

Device Classification Name	Gastroscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K152182
Device Name	Gastroscope And Accessories, Flexible/Rigid
Applicant	ENDOCHOICE INC. 11810 WILLS RD. ALPHARETTA, GA 30009 US Other 510(k) Applications for this Company
Contact	DANIEL HOEFER 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	08/05/2015
Decision Date	12/10/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review