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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 K930991
Device Name BILATERAL TEMPORAL MANDIBULAR JOINT COIL
Applicant
Magnetic Research, Inc.
42 N. University Ave.
Suite 204
Provo,  UT  84601
Applicant Contact SANFORD LARSEN
Correspondent
Magnetic Research, Inc.
42 N. University Ave.
Suite 204
Provo,  UT  84601
Correspondent Contact SANFORD LARSEN
Regulation Number892.1000
Classification Product Code
LNH  
Date Received02/25/1993
Decision Date 06/18/1993
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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