The following data is part of a premarket notification filed by Won Tech Co., Ltd. with the FDA for The Oligio.
| Device ID | K221989 |
| 510k Number | K221989 |
| Device Name: | The Oligio |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | WON TECH Co., Ltd. 64 Techno 8-ro Yuseong-gu, KR 34028 |
| Contact | Hyun Sik Yoon |
| Correspondent | Hyun Sik Yoon WON TECH Co., Ltd. 64 Techno 8-ro Yuseong-gu, KR 34028 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-06 |
| Decision Date | 2022-10-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800022305310 | K221989 | 000 |