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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 K191036
Device Name SyMRI
Applicant
Syntheticmr AB
Storgatan 11
Linkoping,  SE 58223
Applicant Contact Maria Almesaker
Correspondent
Licensale, Inc.
68 Southwoods Terrace
Southbury,  CT  06488
Correspondent Contact Raymond Kelly
Regulation Number892.1000
Classification Product Code
LNH  
Date Received04/18/2019
Decision Date 06/13/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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