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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coil, Magnetic Resonance, Specialty
510(k) Number K171515
Device Name NHAC 16
Applicant
LMT Medical Systems GmbH
Maria-Goeppert-Str. 5
Lubeck,  DE 23562
Applicant Contact Thomas Plein
Correspondent
LMT Medical Systems GmbH
Maria-Goeppert-Str. 5
Lubeck,  DE 23562
Correspondent Contact Thomas Plein
Regulation Number892.1000
Classification Product Code
MOS  
Date Received05/24/2017
Decision Date 07/26/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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