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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 K143711
Device Name Reaxon Plus
Applicant
MEDOVENT GMBH
FRIEDRICH-KOENIG-STR. 3
MAINZ,  DE 55129
Applicant Contact THOMAS FREIER
Correspondent
MEDOVENT GMBH
FRIEDRICH-KOENIG-STR. 3
MAINZ,  DE 55129
Correspondent Contact THOMAS FREIER
Regulation Number882.5275
Classification Product Code
JXI  
Date Received12/29/2014
Decision Date 12/02/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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