The following data is part of a premarket notification filed by Ad-tech Medical Instrument Corporation with the FDA for Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-micro Depth Electrodes, Spencer Probe Depth Electrodes.
| Device ID | K163355 |
| 510k Number | K163355 |
| Device Name: | Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes |
| Classification | Electrode, Depth |
| Applicant | Ad-Tech Medical Instrument Corporation 1901 William Street Racine, WI 53404 |
| Contact | Lisa Theama |
| Correspondent | Gary J Syring QUALITY & REGULATORY ASSOCIATES, LLC. 800 LEVANGER LANE Stoughton, WI 53589 |
| Product Code | GZL |
| CFR Regulation Number | 882.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-30 |
| Decision Date | 2017-04-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841823109576 | K163355 | 000 |
| 00841823109569 | K163355 | 000 |
| 00841823109552 | K163355 | 000 |