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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K872526
Device Name CT PACE CATALOG NUMBER B7950A
Applicant
General Electric Co.
P.O. Box 414
Milwaukee,  WI  53201
Applicant Contact HOWARD, II
Correspondent
General Electric Co.
P.O. Box 414
Milwaukee,  WI  53201
Correspondent Contact HOWARD, II
Regulation Number892.1750
Classification Product Code
JAK  
Date Received06/25/1987
Decision Date 09/23/1987
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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