FDA 510(k) Application Details - K082921

Device Classification Name	Irradiator, Blood To Prevent Graft Versus Host Disease   More FDA Info for this Device
510(K) Number	K082921
Device Name	Irradiator, Blood To Prevent Graft Versus Host Disease
Applicant	RAD SOURCE TECHNOLOGIES, INC. 6825 SHILOH ROAD EAST SUITE B2 ALPHARETTA, GA 30005 US Other 510(k) Applications for this Company
Contact	RANDOL E KIRK Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MOT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/01/2008
Decision Date	02/17/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review