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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 K020027
Device Name FOCUS RADIATION TREATMENT PLANNING SYSTEM
Applicant
Computerized Medical Systems, Inc.
1145 Corporate Lake Dr.
St. Louis,  MO  63132 -1716
Applicant Contact MICHAEL A PARSONS
Correspondent
Computerized Medical Systems, Inc.
1145 Corporate Lake Dr.
St. Louis,  MO  63132 -1716
Correspondent Contact MICHAEL A PARSONS
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received01/04/2002
Decision Date 10/08/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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