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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
Predetermined Change
Control Plan Authorized		 No
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