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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
Applicant Contact MICHAEL A PARSONS
Correspondent
Computerized Medical Systems, Inc.
1145 Corporate Lake Dr.
Suite 100
St. Louis,  MO  63132
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
Predetermined Change
Control Plan Authorized		 No
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