FDA 510(k) Application Details - K071231

Device Classification Name	Detector, Bubble, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K071231
Device Name	Detector, Bubble, Cardiopulmonary Bypass
Applicant	LUNA INNOVATIONS, INC. 3157 STATE STREET BLACKSBURG, VA 24060 US Other 510(k) Applications for this Company
Contact	KRISTINE RICHARDSON 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	05/03/2007
Decision Date	05/17/2007
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