The following data is part of a premarket notification filed by Aci, Inc. with the FDA for Gfx Nerve Ablation System.
| Device ID | K063753 |
| 510k Number | K063753 |
| Device Name: | GFX NERVE ABLATION SYSTEM |
| Classification | Generator, Lesion, Radiofrequency |
| Applicant | ACI, INC. 555 ZANG STREET SUITE 100 Denver, CO 80228 |
| Contact | Clay Anselmo |
| Product Code | GXD |
| CFR Regulation Number | 882.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-12-19 |
| Decision Date | 2007-06-20 |
| Summary: | summary |