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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 K132971
Device Name MONACO
Applicant
IMPAC MEDICAL SYSTEMS, INC.
13723 Riverport Drive
Suite 100
Maryland Heights,  MO  63139
Applicant Contact KATHRYN STINSON
Correspondent
IMPAC MEDICAL SYSTEMS, INC.
13723 Riverport Drive
Suite 100
Maryland Heights,  MO  63139
Correspondent Contact KATHRYN STINSON
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received09/23/2013
Decision Date 11/20/2013
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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