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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Scintillation (Gamma)
510(k) Number K844218
Device Name TOMOGRAPHIC GANTRY
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 Number892.1100
Classification Product Code
IYX  
Date Received10/31/1984
Decision Date 03/01/1985
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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