FDA 510(k) Application Details - K092144

Device Classification Name	Prosthesis, Esophageal   More FDA Info for this Device
510(K) Number	K092144
Device Name	Prosthesis, Esophageal
Applicant	ENDOCHOICE, INC. 1914 J.N. PEASE PLACE CHARLOTTE, NC 28262 US Other 510(k) Applications for this Company
Contact	SHOSHANA FRIEDMAN Other 510(k) Applications for this Contact
Regulation Number	878.3610   More FDA Info for this Regulation Number
Classification Product Code	ESW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/15/2009
Decision Date	02/22/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review