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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 K940874
Device Name MODEL 900GE1500 HEAD/NECK COIL
Applicant
MEDIC, INC.
P.O. BOX 737
925 WEST 6TH STREET
FREMONT,  NE  68025
Applicant Contact RANDALL W JONES
Correspondent
MEDIC, INC.
P.O. BOX 737
925 WEST 6TH STREET
FREMONT,  NE  68025
Correspondent Contact RANDALL W JONES
Regulation Number892.1000
Classification Product Code
LNH  
Date Received02/25/1994
Decision Date 06/03/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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