FDA 510(k) Application Details - K090698

Device Classification Name	Detector, Bubble, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K090698
Device Name	Detector, Bubble, Cardiopulmonary Bypass
Applicant	TERUMO CARDIOVASCULAR SYSTEMS 125 Blue Ball Road Elkton, MD 21921 US Other 510(k) Applications for this Company
Contact	GARRY A COURTNEY Other 510(k) Applications for this Contact
Regulation Number	870.4205   More FDA Info for this Regulation Number
Classification Product Code	KRL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/17/2009
Decision Date	06/08/2009
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	N
Expedited Review