FDA 510(k) Application Details - K091773

Device Classification Name	Endoscopic Access Overtube, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K091773
Device Name	Endoscopic Access Overtube, Gastroenterology-Urology
Applicant	FUJINON, INC. 80 SHELTON TECHNOLOGY CENTER SHELTON, CT 06484 US Other 510(k) Applications for this Company
Contact	JOSEPH M AZARY 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	06/16/2009
Decision Date	08/07/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review