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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Irradiator, Blood To Prevent Graft Versus Host Disease
510(k) Number K963497
Device Name GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0
Applicant
NORDION INTERNATIONAL, INC.
447 MARCH RD.
P.O. BOX 13500
KANATA, ONTARIO,  CA K2K1X8
Applicant Contact GRANT MALKOSKE
Correspondent
NORDION INTERNATIONAL, INC.
447 MARCH RD.
P.O. BOX 13500
KANATA, ONTARIO,  CA K2K1X8
Correspondent Contact GRANT MALKOSKE
Classification Product Code
MOT  
Date Received09/03/1996
Decision Date 11/08/1996
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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