FDA 510(k) Application Details - K070475

Device Classification Name	System, Imaging, Gastrointestinal, Wireless, Capsule   More FDA Info for this Device
510(K) Number	K070475
Device Name	System, Imaging, Gastrointestinal, Wireless, Capsule
Applicant	GIVEN IMAGING LTD. 91 ROCKYSPRING CIRCLE NW CALGARY, ALBERTA T3G 6A1 CA Other 510(k) Applications for this Company
Contact	SHOSHANA FRIEDMAN Other 510(k) Applications for this Contact
Regulation Number	876.1300   More FDA Info for this Regulation Number
Classification Product Code	NEZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/20/2007
Decision Date	05/07/2007
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