FDA 510(k) Application Details - K033954

Device Classification Name	Endoscopic Access Overtube, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K033954
Device Name	Endoscopic Access Overtube, Gastroenterology-Urology
Applicant	USGI MEDICAL, INC. 1140 CALLE CORDILLERA SAN CLEMENTE, CA 92673 US Other 510(k) Applications for this Company
Contact	JEFFREY A ANDERSON Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FED Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/2003
Decision Date	03/19/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review