FDA 510(k) Application Details - K963497

Device Classification Name	Irradiator, Blood To Prevent Graft Versus Host Disease   More FDA Info for this Device
510(K) Number	K963497
Device Name	Irradiator, Blood To Prevent Graft Versus Host Disease
Applicant	NORDION INTERNATIONAL, INC. 447 MARCH RD. P.O. BOX 13500 KANATA, ONTARIO K2K1X8 CA Other 510(k) Applications for this Company
Contact	GRANT MALKOSKE 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	09/03/1996
Decision Date	11/08/1996
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