The following data is part of a premarket notification filed by Ad-tech Medical Instrument Corporation with the FDA for Anchor Bolt (as An Accessory To Depth Electrodes).
| Device ID | K181544 |
| 510k Number | K181544 |
| Device Name: | Anchor Bolt (as An Accessory To Depth Electrodes) |
| Classification | Electrode, Depth |
| Applicant | Ad-Tech Medical Instrument Corporation 400 West Oakwood Road Oak Creek, WI 53154 |
| Contact | Lisa Theama |
| Correspondent | Gary 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 | 2018-06-12 |
| Decision Date | 2018-08-09 |
| Summary: | summary |