The following data is part of a premarket notification filed by Shenb Co Ltd with the FDA for Virtue Rf.
| Device ID | K211562 |
| 510k Number | K211562 |
| Device Name: | Virtue RF |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ShenB Co Ltd ShenB Bldg 148 Seongsui-ro Seoul, KR 04796 |
| Contact | Sunny Kang |
| Correspondent | Connie Hoy Hoy And Associates 3916 N. Potsdam Ave. #4676 Sioux Falls, SD 57104 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-20 |
| Decision Date | 2021-11-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800017100821 | K211562 | 000 |
| 08800017100784 | K211562 | 000 |
| 08800017100753 | K211562 | 000 |
| 08800017100678 | K211562 | 000 |
| 08800017100647 | K211562 | 000 |
| 08800017100616 | K211562 | 000 |
| 08800017100579 | K211562 | 000 |