FDA 510(k) Application Details - K961048

Device Classification Name	Endoscopic Ultrasound System, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K961048
Device Name	Endoscopic Ultrasound System, Gastroenterology-Urology
Applicant	OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. MELVILLE, NY 11747-3157 US Other 510(k) Applications for this Company
Contact	BARRY E SANDS 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	03/15/1996
Decision Date	09/16/1996
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	N
Expedited Review