The following data is part of a premarket notification filed by Viol Co., Ltd. with the FDA for Sylfirm X.
| Device ID | K200185 |
| 510k Number | K200185 |
| Device Name: | SYLFIRM X |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Viol Co., Ltd. C-808, 809 Bundang Technopark C, 744, Pangyo-ro Bundang-gu Seongnam-si, KR 13510 |
| Contact | Chai Kyoung Woo |
| Correspondent | Chai Kyoung Woo Viol Co., Ltd. C-808, 809 Bundang Technopark C, 744, Pangyo-ro Bundang-gu Seongnam-si, KR 13510 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-24 |
| Decision Date | 2020-04-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809502330101 | K200185 | 000 |
| 08809502330187 | K200185 | 000 |
| 08809502330170 | K200185 | 000 |