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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 K003849
Device Name GE ADVANCE NXI PET SYSTEM
Applicant
GE MEDICAL SYSTEMS, INC.
P.O. BOX 414
MILWAUKEE,  WI  53201
Applicant Contact D DUERSTELER
Correspondent
GE MEDICAL SYSTEMS, INC.
P.O. BOX 414
MILWAUKEE,  WI  53201
Correspondent Contact D DUERSTELER
Regulation Number892.1200
Classification Product Code
KPS  
Date Received12/12/2000
Decision Date 12/22/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
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