FDA 510(k) Application Details - DEN120023

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN120023
Device Name	GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM
Applicant	GIVEN IMAGING LTD. HERMON BUILDING NEW INDUSTRIAL PARK PO BOX 258 YOQNEAM 20692 IL Other 510(k) Applications for this Company
Contact	Tim Thomas Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PGD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/29/2012
Decision Date	01/29/2014
Decision	DENG -
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review