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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 K022961
Device Name RTDOSEPLAN
Applicant
Math Resolutions, LLC
5975 Gales Ln.
Columbia,  MD  21045
Applicant Contact WENDEL DEAN RENNER
Correspondent
Math Resolutions, LLC
5975 Gales Ln.
Columbia,  MD  21045
Correspondent Contact WENDEL DEAN RENNER
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received09/06/2002
Decision Date 01/31/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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