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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 K981535
Device Name FOCUS PILOT CONTOURING WORKSTATION
Applicant
Computerized Medical Systems, Inc.
1195 Corporate Lake Dr.
St. Louis,  MO  63132 -1716
Applicant Contact MICHAEL A PARSONS
Correspondent
Computerized Medical Systems, Inc.
1195 Corporate Lake Dr.
St. Louis,  MO  63132 -1716
Correspondent Contact MICHAEL A PARSONS
Regulation Number892.5050
Classification Product Code
IYE  
Date Received04/29/1998
Decision Date 04/02/1999
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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