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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 K010472
Device Name PATIENT DOSE VERIFICATION SYSTEM, MODEL TN-RD-50
Applicant
Thomson & Nielsen Electronics, Ltd.
25 B Northside Rd.
Ottawa, Ontario,  CA K2H 8S1
Applicant Contact ANDREW HARTSHORN
Correspondent
Thomson & Nielsen Electronics, Ltd.
25 B Northside Rd.
Ottawa, Ontario,  CA K2H 8S1
Correspondent Contact ANDREW HARTSHORN
Regulation Number892.5050
Classification Product Code
IYE  
Date Received02/20/2001
Decision Date 05/08/2001
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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