FDA 510(k) Application Details - K161324

Device Classification Name	Irradiator, Blood To Prevent Graft Versus Host Disease   More FDA Info for this Device
510(K) Number	K161324
Device Name	Irradiator, Blood To Prevent Graft Versus Host Disease
Applicant	Best Theratronics Limited 413 March Road Ottawa k2k 0e4 CA Other 510(k) Applications for this Company
Contact	MIKE DE VAN DER SCHUEREN 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	05/11/2016
Decision Date	08/12/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review