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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 K031536
Device Name BRAIN COIL, MODEL 9900GE-64
Applicant
Clinical MR Solutions, LLC
3735 Shadybrook Pl.
Brookfield,  WI  53005
Applicant Contact RALPH S HASHOIAN
Correspondent
Clinical MR Solutions, LLC
3735 Shadybrook Pl.
Brookfield,  WI  53005
Correspondent Contact RALPH S HASHOIAN
Regulation Number892.1000
Classification Product Code
MOS  
Date Received05/16/2003
Decision Date 07/18/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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