The following data is part of a premarket notification filed by Rf Medical Co., Ltd with the FDA for Mygen M-3004 Rf Generator M-3004.
| Device ID | K221277 |
| 510k Number | K221277 |
| Device Name: | Mygen M-3004 RF Generator M-3004 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | RF Medical Co., Ltd #502, 503, 506, 511, 254, Beotkkot-ro, Geumcheon-gu, Seoul, KR 08511 |
| Contact | Kwang S Choi |
| Correspondent | Dave Kim Mtech Group 7505 Fannin St, Suite 610 Houston, TX 77054 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-03 |
| Decision Date | 2022-09-02 |