FDA 510(k) Application Details - K970598

Device Classification Name	Light Source, Fiberoptic, Routine   More FDA Info for this Device
510(K) Number	K970598
Device Name	Light Source, Fiberoptic, Routine
Applicant	UROHEALTH, INC. 3050 REDHILL AVE. COSTA MESA, CA 92626 US Other 510(k) Applications for this Company
Contact	RONALD BERGESON Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FCW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/18/1997
Decision Date	03/12/1997
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