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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 K191186
Device Name Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode
Applicant
Ad-Tech Medical Instrument Corporation
400 West Oakview Parkway
Oak Creek,  WI  53154
Applicant Contact Lisa Theama
Correspondent
QUALITY & REGULATORY ASSOCIATES, LLC.
800 LEVANGER LANE
STOUGHTON,  WI  53589
Correspondent Contact Gary J Syring
Regulation Number882.1310
Classification Product Code
GYC  
Date Received05/03/2019
Decision Date 01/25/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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