FDA 510(k) Application Details - K964037

Device Classification Name	Cystoscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K964037
Device Name	Cystoscope And Accessories, Flexible/Rigid
Applicant	APPLIED FIBEROPTICS, INC. 64 TECHNOLOGY PARK RD. STURBRIDGE, MA 01566-1262 US Other 510(k) Applications for this Company
Contact	GRAHAM BAILLIE Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FAJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/08/1996
Decision Date	02/20/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review