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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 K863180
Device Name THERATRON-PHOENIX
Applicant
Aecl Medical
413 March Rd.
P.O. Box 13140
Kanata, Ontario, Canada,  CA K2K 2B7
Applicant Contact R. K STRIKE
Correspondent
Aecl Medical
413 March Rd.
P.O. Box 13140
Kanata, Ontario, Canada,  CA K2K 2B7
Correspondent Contact R. K STRIKE
Regulation Number892.5750
Classification Product Code
IWB  
Date Received08/18/1986
Decision Date 10/27/1986
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
Recalls CDRH Recalls
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