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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 K946128
Device Name SIMULIX-HP
Applicant
Oldelft Corp. of America
2735 Dorr Ave.
Fairfax,  VA  22031
Applicant Contact CHARLES PATTIE
Correspondent
Oldelft Corp. of America
2735 Dorr Ave.
Fairfax,  VA  22031
Correspondent Contact CHARLES PATTIE
Regulation Number892.5840
Classification Product Code
KPQ  
Date Received12/15/1994
Decision Date 05/12/1995
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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