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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 K944112
Device Name MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
Applicant
GE MEDICAL SYSTEMS
P.O. BOX 414
MILWAUKEE,  WI  53188
Applicant Contact LARRY A KROEGER
Correspondent
GE MEDICAL SYSTEMS
P.O. BOX 414
MILWAUKEE,  WI  53188
Correspondent Contact LARRY A KROEGER
Regulation Number892.1000
Classification Product Code
LNH  
Date Received08/23/1994
Decision Date 12/22/1994
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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