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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 K092285
Device Name PORTABLE DOSIMETER DOSE VERIFICATION SYSTEM, MODEL TD-RD-90
Applicant
Best Medical Canada , Ltd.
413 March Rd.
Ottawa, Ontario,  CA K2K 034
Applicant Contact MARY HERBERT
Correspondent
Best Medical Canada , Ltd.
413 March Rd.
Ottawa, Ontario,  CA K2K 034
Correspondent Contact MARY HERBERT
Regulation Number892.5050
Classification Product Code
IYE  
Date Received07/29/2009
Decision Date 08/28/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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