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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 K183437
Device Name AirRay Subdural Cortical Electrodes
Applicant
CorTec GmbH
Neuer Messplatz 3
Freiburg i. Br.,  DE D-79108
Applicant Contact Mara Assis
Correspondent
CorTec GmbH
Neuer Messplatz 3
Freiburg i. Br.,  DE D-79108
Correspondent Contact Mara Assis
Regulation Number882.1310
Classification Product Code
GYC  
Date Received12/12/2018
Decision Date 03/12/2019
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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