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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 K083504
Device Name GE DISCOVERY NM/CT 570C
Applicant
GE MEDICAL SYSTEMS F.I. HAIFA
4 HAYOZMA ST.
TIRAT HACARMEL,  IL 30200
Applicant Contact LAURENCE BIGIO
Correspondent
UNDERWRITERS LABORATORIES, INC.
333 PFINGSTEN RD.
NORTHBROOK,  IL  60062
Correspondent Contact NED DEVINE
Regulation Number892.1200
Classification Product Code
KPS  
Date Received11/26/2008
Decision Date 12/12/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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