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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrode, cortical
510(k) Number K192764
Device Name NeuroOne Cortical Electrode
Applicant
NeuroOne, Inc.
10901 Red Circle Dr., Suite 150
minnetonka,  MN  55343
Applicant Contact debra kridner
Correspondent
Debra J Kridner
10901 Red Circle Dr., Suite 150
minnetonka,  MN  55343
Correspondent Contact debra kridner
Regulation Number882.1310
Classification Product Code
GYC  
Date Received09/30/2019
Decision Date 11/26/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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