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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 K870221
Device Name T.O.P. 2000 (TOMOGRAPHIC ORIENTATED PLANNING)
Applicant
Kermath Mfg. Corp.
5105 Tollview Dr. Suite 170
Rolling Meadows,  IL  60008
Applicant Contact JIM LAMBRECHT
Correspondent
Kermath Mfg. Corp.
5105 Tollview Dr. Suite 170
Rolling Meadows,  IL  60008
Correspondent Contact JIM LAMBRECHT
Regulation Number892.5840
Classification Product Code
KPQ  
Date Received01/21/1987
Decision Date 05/12/1987
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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