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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 K834281
Device Name RAD II SIMULATOR
Applicant
Haynes Radiation Ltd., Inc.
P.O. Box 1312
Alameda,  CA  94501
Applicant Contact GENE HAYNES
Correspondent
Haynes Radiation Ltd., Inc.
P.O. Box 1312
Alameda,  CA  94501
Correspondent Contact GENE HAYNES
Regulation Number892.5840
Classification Product Code
KPQ  
Date Received11/02/1983
Decision Date 12/29/1983
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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