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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source, Brachytherapy, Radionuclide
510(k) Number K902488
Device Name MODIFIED CASS SYSTEM
Applicant
Medical Instrumentation & Diagnostics Corp.(Midco)
806 Sagebrush Ct. Southeast
Albuquerque,  NM  87123
Applicant Contact HARDY, M.D.
Correspondent
Medical Instrumentation & Diagnostics Corp.(Midco)
806 Sagebrush Ct. Southeast
Albuquerque,  NM  87123
Correspondent Contact HARDY, M.D.
Regulation Number892.5730
Classification Product Code
KXK  
Date Received05/30/1990
Decision Date 12/07/1990
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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