FDA 510(k) Application Details - K061646

Device Classification Name	Cystourethroscope   More FDA Info for this Device
510(K) Number	K061646
Device Name	Cystourethroscope
Applicant	LASERSCOPE 3070 ORCHARD DR. SAN JOSE, CA 95134-2011 US Other 510(k) Applications for this Company
Contact	PAUL HARDIMAN Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FBO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/12/2006
Decision Date	06/27/2006
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	Y
Expedited Review