FDA 510(k) Application Details - K072507

Device Classification Name	More FDA Info for this Device
510(K) Number	K072507
Device Name	ENDOWAVE INFUSION SYSTEM
Applicant	EKOS CORP. 11911 N CREEK PARKWAY SOUTH BOTHELL, WA 98011 US Other 510(k) Applications for this Company
Contact	JOCELYN KERSTEN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/06/2007
Decision Date	10/04/2007
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