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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 K921740
Device Name COMPUTER ASSISTED STEREOTACTIC SURGERY -- MODIFIED
Applicant
Medical Instrumentation & Diagnostics Corp.(Midco)
806 Sagebrush Ct. Southeast
Albuquerque,  NM  87123
Applicant Contact T. L HARDY
Correspondent
Medical Instrumentation & Diagnostics Corp.(Midco)
806 Sagebrush Ct. Southeast
Albuquerque,  NM  87123
Correspondent Contact T. L HARDY
Regulation Number892.5050
Classification Product Code
IYE  
Date Received04/13/1992
Decision Date 04/07/1993
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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