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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cuff, Nerve
510(k) Number K180222
Device Name Reaxon Plus
Applicant
Medovent GmbH
Friedrich-Koenig-Str. 3
Mainz,  DE 55129
Applicant Contact Peter Meier
Correspondent
Medovent GmbH
Friedrich-Koenig-Str. 3
Mainz,  DE 55129
Correspondent Contact Peter Meier
Regulation Number882.5275
Classification Product Code
JXI  
Date Received01/25/2018
Decision Date 04/24/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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