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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 K191346
Device Name Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)
Applicant
Blackrock Microsystems
630 Komas Dr.
Suite 200
Salt Lake City,  UT  84108
Applicant Contact Rachelle Frischknecht
Correspondent
Blackrock Microsystems
630 Komas Dr.
Suite 200
Salt Lake City,  UT  84108
Correspondent Contact Rachelle Frischknecht
Regulation Number882.1310
Classification Product Code
GYC  
Date Received05/20/2019
Decision Date 02/14/2020
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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