FDA 510(k) Application Details - K132535

Device Classification Name	Ligator, Esophageal   More FDA Info for this Device
510(K) Number	K132535
Device Name	Ligator, Esophageal
Applicant	ENDOCHOICE, INC. 11810 WILLS ROAD ALPHARETTA, GA 30009 US Other 510(k) Applications for this Company
Contact	DANIEL HOEFER Other 510(k) Applications for this Contact
Regulation Number	876.4400   More FDA Info for this Regulation Number
Classification Product Code	MND Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/13/2013
Decision Date	08/23/2013
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