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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 K190246
Device Name NeuroShield
Monarch Bioimplants GmbH
Platz 4
Root,  CH 6039
Applicant Contact Rivelino Montenegro
Monarch Bioimplants GmbH
Platz 4
Root,  CH 6039
Correspondent Contact Rivelino Montenegro
Regulation Number882.5275
Classification Product Code
Date Received02/06/2019
Decision Date 05/31/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No