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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 K923025
Device Name SIGNA BREAST COIL AND ARRAY ACCESSORY
Applicant
GE MEDICAL SYSTEMS
PO BOX 414
MILWAUKEE,  WI  53201
Applicant Contact LARRY A DROGER
Correspondent
GE MEDICAL SYSTEMS
PO BOX 414
MILWAUKEE,  WI  53201
Correspondent Contact LARRY A DROGER
Regulation Number892.1000
Classification Product Code
LNH  
Date Received06/23/1992
Decision Date 11/27/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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