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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Radiation Therapy, Neutron, Medical
510(k) Number K063691
Device Name NEUTRON THERAPY SYSTEM
Applicant
Northern Illinois Univ. Outreach
555 Thirteenth St. NW
Washington,  DC  20004
Applicant Contact JONATHAN S KAHAN
Correspondent
Northern Illinois Univ. Outreach
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact JONATHAN S KAHAN
Regulation Number892.5300
Classification Product Code
IWL  
Date Received12/12/2006
Decision Date 01/31/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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