FDA 510(k) Application Details - K092623

Device Classification Name	More FDA Info for this Device
510(K) Number	K092623
Device Name	F.A.S.T. SYSTEM SED AND CXD
Applicant	GENESIS MEDICAL INTERVENTIONAL, INC. 3637 BERNAL AVENUE PLEASANTON, CA 94566 US Other 510(k) Applications for this Company
Contact	ANNE WORDEN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/26/2009
Decision Date	10/30/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review