FDA 510(k) Application Details - K042960

Device Classification Name	System, Imaging, Esophageal, Wireless, Capsule   More FDA Info for this Device
510(K) Number	K042960
Device Name	System, Imaging, Esophageal, Wireless, Capsule
Applicant	GIVEN IMAGING LTD. 13 HAYETZIRA STREET NEW INDUSTRIAL ZONE YOKNEAM 20692 IL Other 510(k) Applications for this Company
Contact	SHOSH 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	10/27/2004
Decision Date	11/24/2004
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