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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 K837346
Device Name MODEL GAMMACELL 1000
Applicant
Atomic Energy of Canada
413 March Rd.
P.O. Box 13140
Kanata, Ontario, Canada,  CA K2K 2B7
Correspondent
Atomic Energy of Canada
413 March Rd.
P.O. Box 13140
Kanata, Ontario, Canada,  CA K2K 2B7
Classification Product Code
MOT  
Date Received03/16/1983
Decision Date 06/24/1983
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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