FDA 510(k) Application Details - K060805

Device Classification Name	System, Imaging, Esophageal, Wireless, Capsule   More FDA Info for this Device
510(K) Number	K060805
Device Name	System, Imaging, Esophageal, Wireless, Capsule
Applicant	GIVEN IMAGING LTD. SHAAR YOKNEAM NEW INDUSTRIAL ZONE, YOKNEAM (P.O.BOX 258) 20692 IL 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	NSI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/24/2006
Decision Date	05/24/2006
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