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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 K933295
Device Name MODEL 700GE1500 CARDIAC VASCULAR COIL FOR G.E. 1.5T SIGNA
Applicant
MEDIC, INC.
925 WEST 6TH ST.
P.O. BOX 737
FREMONT,  NE  68025
Applicant Contact RANDALL W JONES
Correspondent
MEDIC, INC.
925 WEST 6TH ST.
P.O. BOX 737
FREMONT,  NE  68025
Correspondent Contact RANDALL W JONES
Regulation Number892.1000
Classification Product Code
LNH  
Date Received07/07/1993
Decision Date 03/17/1994
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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