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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, Charged-Particle, Medical
510(k) Number K891261
Device Name INTRAOPERATIVE RADIATION THERAPY DEVICES
Applicant
General Electric Co.
P.O. Box 414
Milwaukee,  WI  53201
Applicant Contact KROGER, PHD
Correspondent
General Electric Co.
P.O. Box 414
Milwaukee,  WI  53201
Correspondent Contact KROGER, PHD
Regulation Number892.5050
Classification Product Code
LHN  
Date Received03/08/1989
Decision Date 04/26/1989
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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