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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 K852609
Device Name MEVASSIST(SETUP CONTROLLER)
Applicant
Magus Microcontrollers, Inc.
4252 Commerce Cir.
Victoria, B.C.
Canada V8z4mz,  CA
Applicant Contact LEO FORD
Correspondent
Magus Microcontrollers, Inc.
4252 Commerce Cir.
Victoria, B.C.
Canada V8z4mz,  CA
Correspondent Contact LEO FORD
Regulation Number892.5050
Classification Product Code
IYE  
Date Received06/19/1985
Decision Date 02/06/1986
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
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