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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 K003685
Device Name MODEL 342GE-64 HIGH RESOLUTION BRAIN COIL
Applicant
MEDICAL ADVANCES, INC.
10437 INNOVATION DR.
MILWAUKEE,  WI  53226
Applicant Contact MICHAEL LEIGH
Correspondent
MEDICAL ADVANCES, INC.
10437 INNOVATION DR.
MILWAUKEE,  WI  53226
Correspondent Contact MICHAEL LEIGH
Regulation Number892.1000
Classification Product Code
MOS  
Date Received11/30/2000
Decision Date 12/22/2000
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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