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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Spectroscopic
510(k) Number K984167
FOIA Releasable 510(k) K984167
Device Name SAGE 7
Applicant
GE Medical Systems
3200 N Grandview Blvd.
Waukesha,  WI  53188
Applicant Contact LARRY A KROGER
Correspondent
GE Medical Systems
3200 N Grandview Blvd.
Waukesha,  WI  53188
Correspondent Contact LARRY A KROGER
Regulation Number892.1000
Classification Product Code
LNI  
Date Received11/20/1998
Decision Date 01/12/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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