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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 K915691
Device Name FOCUS RTP
Applicant
COMPUTERIZED MEDICAL SYSTEMS, INC.
56 WORTHINGTON DR.
MARYLAND HEIGHTS,  MO  63043 -3806
Applicant Contact KIM ORT
Correspondent
COMPUTERIZED MEDICAL SYSTEMS, INC.
56 WORTHINGTON DR.
MARYLAND HEIGHTS,  MO  63043 -3806
Correspondent Contact KIM ORT
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received12/23/1991
Decision Date 02/16/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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