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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 K864910
Device Name MEVACHECK
Applicant
Magus Microcontrollers, Inc.
4252 Commerce Cir.
Victoria, B.C.
Canada V8z4mz,  CA
Applicant Contact MORRIS, PHD
Correspondent
Magus Microcontrollers, Inc.
4252 Commerce Cir.
Victoria, B.C.
Canada V8z4mz,  CA
Correspondent Contact MORRIS, PHD
Regulation Number892.5050
Classification Product Code
IYE  
Date Received12/15/1986
Decision Date 03/16/1987
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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