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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 K914209
Device Name MODEL 310GE-64: WHOLE VOLUME NECK COIL
Applicant
MEDICAL ADVANCES, INC.
10431 w. watertown plank rd.
p.o. box 26425
milwaukee,  WI  53226 0425
Contact thomas tynes
Regulation Number892.1000
Classification Product Code
LNH  
Date Received09/19/1991
Decision Date 03/05/1992
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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