The following data is part of a premarket notification filed by Ad-tech Medical Instrument Corporation with the FDA for 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.
| Device ID | K191186 |
| 510k 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 |
| Classification | Electrode, Cortical |
| Applicant | Ad-Tech Medical Instrument Corporation 400 West Oakview Parkway Oak Creek, WI 53154 |
| Contact | Lisa Theama |
| Correspondent | Gary J Syring QUALITY & REGULATORY ASSOCIATES, LLC. 800 LEVANGER LANE Stoughton, WI 53589 |
| Product Code | GYC |
| CFR Regulation Number | 882.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-03 |
| Decision Date | 2020-01-25 |