FDA 510(k) Application Details - K974210

Device Classification Name	Irradiator, Blood To Prevent Graft Versus Host Disease   More FDA Info for this Device
510(K) Number	K974210
Device Name	Irradiator, Blood To Prevent Graft Versus Host Disease
Applicant	RAD-SOURCE, INC. 475 RAMBLEWOOD DR., SUITE 207 CORAL SPRINGS, FL 33071 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	11/10/1997
Decision Date	03/30/1998
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