FDA 510(k) Application Details - K050808

Device Classification Name	Angioscope   More FDA Info for this Device
510(K) Number	K050808
Device Name	Angioscope
Applicant	CARDIO-OPTICS, INC. 2477 55TH ST., SUITE 120 BOULDER, CO 80301 US Other 510(k) Applications for this Company
Contact	LARRY BLANKENSHIP Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	LYK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/30/2005
Decision Date	07/28/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review