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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, planning, radiation therapy treatment
510(k) Number K002147
Device Name FOCUS
Applicant
COMPUTERIZED MEDICAL SYSTEMS, INC.
1145 CORPORATE LAKE DR.
SUITE 100
ST. LOUIS,  MO  63132 -1716
Applicant Contact MICHAEL A PARSONS
Correspondent
COMPUTERIZED MEDICAL SYSTEMS, INC.
1145 CORPORATE LAKE DR.
SUITE 100
ST. LOUIS,  MO  63132 -1716
Correspondent Contact MICHAEL A PARSONS
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received07/17/2000
Decision Date 10/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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