FDA 510(k) Application Details - DEN010002

Device Classification Name	System, Imaging, Gastrointestinal, Wireless, Capsule   More FDA Info for this Device
510(K) Number	DEN010002
Device Name	System, Imaging, Gastrointestinal, Wireless, Capsule
Applicant	GIVEN IMAGING LTD. 117 AHUZAH ST. RA'ANANNA 43373 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	NEZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/11/2001
Decision Date	08/01/2001
Decision	DENG -
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review