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 Number | 882.1310
|
Classification Product Code |
|
Date Received | 05/03/2019 |
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
|
|
|