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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 K932552
Device Name SPORTS MEDICINE QUADRATURE SHOULDER COIL
Applicant
Magnetic Research, Inc.
42 N. University Ave.
Suite 204
Provo,  UT  84601
Applicant Contact WENDELL GIBBY
Correspondent
Magnetic Research, Inc.
42 N. University Ave.
Suite 204
Provo,  UT  84601
Correspondent Contact WENDELL GIBBY
Regulation Number892.1000
Classification Product Code
LNH  
Date Received05/26/1993
Decision Date 02/09/1994
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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