FDA 510(k) Application Details - K003807

Device Classification Name	Cystoscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K003807
Device Name	Cystoscope And Accessories, Flexible/Rigid
Applicant	GLOBAL ENDOSCOPY, INC. 914 W. ESTES CT. SCHAUMBURG, IL 60193-4426 US Other 510(k) Applications for this Company
Contact	NICK MIRCEA 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	12/08/2000
Decision Date	02/22/2001
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