The following data is part of a premarket notification filed by Starmed Co., Ltd. with the FDA for Viva Combo Rf System.
| Device ID | K163450 |
| 510k Number | K163450 |
| 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 Gyeonggi-do, KR 10355 |
| Contact | Jun-young Jung |
| Correspondent | Jun-young Jung STARmed Co., Ltd. B-dong, 4F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si Gyeonggi-do, KR 10355 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-08 |
| Decision Date | 2017-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 28809306760559 | K163450 | 000 |
| 28809306760023 | K163450 | 000 |
| 08809306769060 | K163450 | 000 |
| 08809306769015 | K163450 | 000 |