FDA 510(k) Application Details - K092221

Device Classification Name	Endoscopic Access Overtube, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K092221
Device Name	Endoscopic Access Overtube, Gastroenterology-Urology
Applicant	UNITED STATES ENDOSCOPY GROUP, INC. 5976 HEISLEY RD. MENTOR, OH 44060 US Other 510(k) Applications for this Company
Contact	CRAIG L MOORE 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	07/22/2009
Decision Date	10/20/2009
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