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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 K935015
Device Name QUADRATURE SMALL EXTREMITY COIL
Applicant
MAGNETIC RESEARCH, INC.
42 NORTH UNIVERSITY AVE.
SUITE 204
PROVO,  UT  84601
Applicant Contact WENDELL A GIBBY
Correspondent
MAGNETIC RESEARCH, INC.
42 NORTH UNIVERSITY AVE.
SUITE 204
PROVO,  UT  84601
Correspondent Contact WENDELL A GIBBY
Regulation Number892.1000
Classification Product Code
LNH  
Date Received10/19/1993
Decision Date 05/10/1994
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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