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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 imaging
510(k) Number K954355
Device Name ADVANTAGE WINDOWS 3D WITH NAVIGATOR OPTION
Applicant
GENERAL ELECTRIC CO.
P0 BOX 414
MILWAUKEE,  WI 
Applicant Contact LARRY A KROGER
Correspondent
GENERAL ELECTRIC CO.
P0 BOX 414
MILWAUKEE,  WI 
Correspondent Contact LARRY A KROGER
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
JAK  
Date Received09/18/1995
Decision Date 11/14/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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