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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 K812726
Device Name KERMATH THERAPY SIMULATOR
Applicant
Kermath Mfg. Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Kermath Mfg. Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number892.5840
Classification Product Code
KPQ  
Date Received09/28/1981
Decision Date 11/05/1981
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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