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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 K920227
Device Name QUADRATURE SHOULDER CONTOUR COIL
Applicant
MAGNETIC RESEARCH, INC.
695 EAST 1700 NORTH
MAPLETON,  UT  84664
Applicant Contact WENDELL A GIBBY
Correspondent
MAGNETIC RESEARCH, INC.
695 EAST 1700 NORTH
MAPLETON,  UT  84664
Correspondent Contact WENDELL A GIBBY
Regulation Number892.1000
Classification Product Code
LNH  
Date Received01/17/1992
Decision Date 08/24/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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