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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 K110730
Device Name MONACO RTP SYSTEM
Applicant
COMPUTERIZED MEDICAL SYSTEMS, INC.
13723 RIVERPORT DR
SUITE 100
MARYLAND HEIGHTS,  MO  63043
Applicant Contact KATHRYN STINSON
Correspondent
COMPUTERIZED MEDICAL SYSTEMS, INC.
13723 RIVERPORT DR
SUITE 100
MARYLAND HEIGHTS,  MO  63043
Correspondent Contact KATHRYN STINSON
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received03/16/2011
Decision Date 06/24/2011
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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