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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 K885081
Device Name SIMRITE VERIFICATION AND SIMULATION SYSTEM
Applicant
Haynes Radiation Ltd., Inc.
2033 Clement Ave.
Bldg. 31
Alameda,  CA  94501
Applicant Contact STEPHEN E HAYNES
Correspondent
Haynes Radiation Ltd., Inc.
2033 Clement Ave.
Bldg. 31
Alameda,  CA  94501
Correspondent Contact STEPHEN E HAYNES
Regulation Number892.5840
Classification Product Code
KPQ  
Date Received12/09/1988
Decision Date 03/22/1989
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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