FDA 510(k) Application Details - K082044

Device Classification Name	Endoscopic Tissue Approximation Device   More FDA Info for this Device
510(K) Number	K082044
Device Name	Endoscopic Tissue Approximation Device
Applicant	BAROSENSE, INC 3698-C HAVEN AVENUE REDWOOD CITY, CA 94063 US Other 510(k) Applications for this Company
Contact	DANIEL J BALBIERZ Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	OCW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/18/2008
Decision Date	05/11/2010
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