FDA 510(k) Application Details - K950719

Device Classification Name	Urethrotome   More FDA Info for this Device
510(K) Number	K950719
Device Name	Urethrotome
Applicant	OLYMPUS AMERICA, INC. 4 NEVADA DR. LAKE SUCCESS, NY 11042-1179 US Other 510(k) Applications for this Company
Contact	BARRY E SANDS Other 510(k) Applications for this Contact
Regulation Number	876.4770   More FDA Info for this Regulation Number
Classification Product Code	EZO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/16/1995
Decision Date	12/11/1996
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	N
Expedited Review