The following data is part of a premarket notification filed by Saeshin Precision Co., Ltd. with the FDA for Traus Endo.
| Device ID | K212043 |
| 510k Number | K212043 |
| Device Name: | TRAUS ENDO |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | Saeshin Precision Co., Ltd. # 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun Daegu, KR 711-814 |
| Contact | Nam-Gung San |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 18881 Von Karman Ave. STE 160 Irvine, CA 92612 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-30 |
| Decision Date | 2022-06-24 |