The following data is part of a premarket notification filed by Applied Medical Resources Corporation with the FDA for Voyant Maryland Fusion Device With Single-step Activation (eb212, Eb213, Eb214).
| Device ID | K222284 |
| 510k Number | K222284 |
| Device Name: | Voyant Maryland Fusion Device With Single-Step Activation (EB212, EB213, EB214) |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Applied Medical Resources Corporation 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Contact | Blake Stacy |
| Correspondent | Blake Stacy Applied Medical Resources Corporation 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-01 |
| Decision Date | 2022-10-14 |