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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 K030199
Device Name GE MOBILE DISCOVERY ST PET CT IMAGING SYSTEM
Applicant
General Electric Co.
P.O. Box 414
Milwaukee,  WI  53201
Applicant Contact DAVID DUERSTELER
Correspondent
General Electric Co.
P.O. Box 414
Milwaukee,  WI  53201
Correspondent Contact DAVID DUERSTELER
Regulation Number892.1200
Classification Product Code
KPS  
Date Received01/21/2003
Decision Date 02/11/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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