FDA 510(k) Application Details - K040949

Device Classification Name	Light Source, Endoscope, Xenon Arc   More FDA Info for this Device
510(K) Number	K040949
Device Name	Light Source, Endoscope, Xenon Arc
Applicant	ACUEITY, INC. 100 HAMILTON AVE., SUITE 140 PALO ALTO, CA 94301 US Other 510(k) Applications for this Company
Contact	NANCY LINCE Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	GCT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/12/2004
Decision Date	05/07/2004
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	Y
Expedited Review