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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 K905104
Device Name MODEL 3100-64: QUADRATURE SPINE COIL
Applicant
MEDICAL ADVANCES, INC.
10431 W. WATERTOWN PLANK RD.
P.O. BOX 26425
MILWAUKEE,  WI  53226 -0425
Applicant Contact THOMAS E TYNES
Correspondent
MEDICAL ADVANCES, INC.
10431 W. WATERTOWN PLANK RD.
P.O. BOX 26425
MILWAUKEE,  WI  53226 -0425
Correspondent Contact THOMAS E TYNES
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/13/1990
Decision Date 01/08/1991
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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