FDA 510(k) Application Details - K964061

Device Classification Name	Angioscope   More FDA Info for this Device
510(K) Number	K964061
Device Name	Angioscope
Applicant	W.L. GORE & ASSOCIATES,INC 1505 N. FOURTH ST. P.O. BOX 3000 FLAGSTAFF, AZ 86003-3000 US Other 510(k) Applications for this Company
Contact	DAWN LOPEZ 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	10/10/1996
Decision Date	02/20/1997
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