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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 K873580
Device Name MHTI CT-SIM RADIATION THERAPY TREATMENT SIMULATOR
Applicant
Medical High Technology International, Inc.
14155 58th St., N.
Clearwater,  FL  34620
Applicant Contact THOMAS P MONKUS
Correspondent
Medical High Technology International, Inc.
14155 58th St., N.
Clearwater,  FL  34620
Correspondent Contact THOMAS P MONKUS
Regulation Number892.5840
Classification Product Code
KPQ  
Date Received08/27/1987
Decision Date 11/02/1987
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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