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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Radiation Therapy, Radionuclide
510(k) Number K850543
Device Name THERATRON 780C A RADIONUCLIDE RADIATION THERAPY SY
Applicant
Atomic Energy of Canada
413 March Rd.
P.O. Box 13140
Kanata, Ontario, Canada,  CA K2K 2B7
Applicant Contact SLOBODIAN
Correspondent
Atomic Energy of Canada
413 March Rd.
P.O. Box 13140
Kanata, Ontario, Canada,  CA K2K 2B7
Correspondent Contact SLOBODIAN
Regulation Number892.5750
Classification Product Code
IWB  
Date Received02/11/1985
Decision Date 05/10/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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