FDA 510(k) Application Details - K093187

Device Classification Name	Colonoscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K093187
Device Name	Colonoscope And Accessories, Flexible/Rigid
Applicant	AVANTIS MEDICAL SYSTEMS, INC. 263 SANTA ANA CT. SUNNYVALE, CA 94085 US Other 510(k) Applications for this Company
Contact	ELAINE APLAON Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FDF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/09/2009
Decision Date	11/05/2009
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