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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Simulation, Radiation Therapy
510(k) Number K910367
Device Name COMPUTE-RX-COMP (TM)
Applicant
Medicalibration Physics Consultant Services, Inc.
1463 Harvest Dr.
Ripon,  CA  95366
Applicant Contact RALPH H RYDMAN
Correspondent
Medicalibration Physics Consultant Services, Inc.
1463 Harvest Dr.
Ripon,  CA  95366
Correspondent Contact RALPH H RYDMAN
Regulation Number892.5840
Classification Product Code
KPQ  
Date Received01/29/1991
Decision Date 05/30/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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