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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K837347
Device Name LINEAR ACCELERATOR THERAC 25
Applicant
Atomic Energy of Canada
413 March Rd.
P.O. Box 13140
Kanata, Ontario, Canada,  CA K2K 2B7
Applicant Contact THERATRONICS INTL
Correspondent
Atomic Energy of Canada
413 March Rd.
P.O. Box 13140
Kanata, Ontario, Canada,  CA K2K 2B7
Correspondent Contact THERATRONICS INTL
Regulation Number892.5050
Classification Product Code
IYE  
Date Received04/04/1983
Decision Date 06/24/1983
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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