FDA 510(k) Application Details - K050253

Device Classification Name	Endoscopic Access Overtube, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K050253
Device Name	Endoscopic Access Overtube, Gastroenterology-Urology
Applicant	USGI MEDICAL 1140 CALLE CORDILLERA SAN CLEMENTE, CA 92673 US Other 510(k) Applications for this Company
Contact	MARY LOU MOONEY 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	02/03/2005
Decision Date	02/28/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review