FDA 510(k) Application Details - K040494

Device Classification Name	System, Imaging, Gastrointestinal, Wireless, Capsule   More FDA Info for this Device
510(K) Number	K040494
Device Name	System, Imaging, Gastrointestinal, Wireless, Capsule
Applicant	UNITED STATES ENDOSCOPY GROUP, INC. 5976 HEISLEY RD. MENTOR, OH 44060 US Other 510(k) Applications for this Company
Contact	GRETCHEN Y COHEN 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	02/26/2004
Decision Date	06/23/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review