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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 K852804
Device Name MEDCYC SUPERCONDUCT ISOCEN NEUTRON THERAPY SYS
Applicant
Medcyc. Corp.
609 Beech St.
East Lansing,  MI  48823
Applicant Contact WILLIAM R NUM,MY
Correspondent
Medcyc. Corp.
609 Beech St.
East Lansing,  MI  48823
Correspondent Contact WILLIAM R NUM,MY
Regulation Number892.5300
Classification Product Code
IWL  
Date Received07/03/1985
Decision Date 10/15/1985
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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