The following data is part of a premarket notification filed by Shenb Co Ltd. with the FDA for Vivace Electrosurgical Device.
| Device ID | K193070 |
| 510k Number | K193070 |
| Device Name: | VIVACE Electrosurgical Device |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ShenB Co Ltd. Shenb Bldg 148, Seongsui-ro Seongdong-gu, KR 04796 |
| Contact | Sun Young Kang |
| Correspondent | Rachel Lord Aesthetics Biomedical 4602 N 16th St Suite 300 Phoenix, AZ 85016 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-04 |
| Decision Date | 2021-04-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800017100463 | K193070 | 000 |
| 08800017100883 | K193070 | 000 |