The following data is part of a premarket notification filed by Starmed Co., Ltd. with the FDA for Viva Combo Rf System.
| Device ID | K183538 |
| 510k Number | K183538 |
| Device Name: | VIVA Combo RF System |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | STARmed Co., Ltd. B-dong, 4F, 158, Haneulmaeul-ro, IlsanDong-gu Goyang-si, KR 10355 |
| Contact | Jun-young Jung |
| Correspondent | Jun-young Jung STARmed Co., Ltd. B-dong, 4F, 158, Haneulmaeul-ro, IlsanDong-gu Goyang-si, KR 10355 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-19 |
| Decision Date | 2019-01-17 |
| Summary: | summary |