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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 K954353
Device Name MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
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  
Date Received09/18/1995
Decision Date 04/12/1996
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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