FDA 510(k) Application Details - K092097

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K092097
Device Name	Introducer, Catheter
Applicant	A.B. KORKOR MEDICAL, INC. 400 NORTH RAND ROAD NORTH BARRINGTON, IL 60010 US Other 510(k) Applications for this Company
Contact	ANDREW BLACK Other 510(k) Applications for this Contact
Regulation Number	870.1340   More FDA Info for this Regulation Number
Classification Product Code	DYB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/14/2009
Decision Date	05/06/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review