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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 K902663
Device Name GE QUADRATURE T/L SPINE SURF COIL, M1085AP/M1285AP
Applicant
GENERAL ELECTRIC CO.
P.O. BOX 414
MILWAUKEE,  WI  53201
Applicant Contact KROGER, PHD
Correspondent
GENERAL ELECTRIC CO.
P.O. BOX 414
MILWAUKEE,  WI  53201
Correspondent Contact KROGER, PHD
Regulation Number892.1000
Classification Product Code
LNH  
Date Received06/18/1990
Decision Date 09/20/1990
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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