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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 K071938
Device Name MONACO RTP SYSTEM
Applicant
COMPUTERIZED MEDICAL SYSTEMS, INC.
1145 CORPORATE LAKE DR.
ST. LOUIS,  MO  63132 -1716
Applicant Contact KATHRYN STINSON
Correspondent
COMPUTERIZED MEDICAL SYSTEMS, INC.
1145 CORPORATE LAKE DR.
ST. LOUIS,  MO  63132 -1716
Correspondent Contact KATHRYN STINSON
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received07/13/2007
Decision Date 10/01/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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