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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 K905512
Device Name ANTERIOR NECK CONTOUR COIL
Applicant
Magnetic Research, Inc.
695 E. 1700 N.
Mapleton,  UT  84664
Applicant Contact SANDY LARSON
Correspondent
Magnetic Research, Inc.
695 E. 1700 N.
Mapleton,  UT  84664
Correspondent Contact SANDY LARSON
Regulation Number892.1000
Classification Product Code
LNH  
Date Received12/10/1990
Decision Date 03/07/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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