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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coil, Magnetic Resonance, Specialty
510(k) Number K003097
Device Name BRAIN COIL, MODEL 9800GE-64
Applicant
Midwest Rf, LLC
535 Norton Dr.
P.O. Box 348
Hartland,  WI  53029
Applicant Contact RALPH S HASHOIAN
Correspondent
Midwest Rf, LLC
535 Norton Dr.
P.O. Box 348
Hartland,  WI  53029
Correspondent Contact RALPH S HASHOIAN
Regulation Number892.1000
Classification Product Code
MOS  
Date Received10/03/2000
Decision Date 12/28/2000
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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