FDA 510(k) Application Details - K042140

Device Classification Name	Endoscopic Ultrasound System, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K042140
Device Name	Endoscopic Ultrasound System, Gastroenterology-Urology
Applicant	OLYMPUS CORPORATION TWO CORPORATE CENTER DRIVE MELVILLE, NY 11747-3157 US Other 510(k) Applications for this Company
Contact	TINA STEFFANIE-OAK Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	ODG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/09/2004
Decision Date	08/18/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review