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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Simulation, Radiation Therapy
510(k) Number K854880
Device Name RADIATION BEAM DATA ACQUISTIOIN SYSTEMS
Applicant
Computerized Medical Systems, Inc.
2294 Weldon Pkwy.
St. Louis,  MO  63146
Applicant Contact MELVIN MCCOLLUM
Correspondent
Computerized Medical Systems, Inc.
2294 Weldon Pkwy.
St. Louis,  MO  63146
Correspondent Contact MELVIN MCCOLLUM
Regulation Number892.5840
Classification Product Code
KPQ  
Date Received12/06/1985
Decision Date 01/10/1986
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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