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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K915470
Device Name OPTIMA NUCLEAR TOMOGRAPHY STYSTEM
Applicant
General Electric Co.
P.O. Box 414
Milwaukee,  WI  53201
Applicant Contact LARRY KROGER
Correspondent
General Electric Co.
P.O. Box 414
Milwaukee,  WI  53201
Correspondent Contact LARRY KROGER
Regulation Number892.1200
Classification Product Code
KPS  
Date Received12/06/1991
Decision Date 04/16/1992
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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