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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 K041220
Device Name GE DISCOVERY ST SYSTEM
Applicant
GE MEDICAL SYSTEMS
P.O. 414
MILWAUKEE,  WI  53188
Applicant Contact DAVID DUERSTELER
Correspondent
GE MEDICAL SYSTEMS
P.O. 414
MILWAUKEE,  WI  53188
Correspondent Contact DAVID DUERSTELER
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received05/10/2004
Decision Date 06/15/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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