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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 K030821
Device Name SIMUPLAN TREATMENT PLANNING SYSTEM, MODEL V. 7.5
Applicant
Simuplan S.L.
Miguel Hernandez 25
La Eliana Valencia,  ES 46183
Applicant Contact CONRADO PLA
Correspondent
Simuplan S.L.
Miguel Hernandez 25
La Eliana Valencia,  ES 46183
Correspondent Contact CONRADO PLA
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received03/14/2003
Decision Date 09/17/2003
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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