The following data is part of a premarket notification filed by Applied Medical with the FDA for Voyant Fine Fusion Device (eb230).
| Device ID | K202818 |
| 510k Number | K202818 |
| Device Name: | Voyant Fine Fusion Device (EB230) |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Applied Medical 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Contact | Blake Stacy |
| Correspondent | Blake Stacy Applied Medical 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-24 |
| Decision Date | 2021-12-16 |