The following data is part of a premarket notification filed by Saeshin Precision Co., Ltd. with the FDA for Traus Endo.
| Device ID | K143411 |
| 510k Number | K143411 |
| 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 711814 |
| Contact | Sae Kwan Choi |
| Correspondent | Sae Kwan Choi SAESHIN PRECISION CO., LTD. 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun Daegu, KR 711814 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-28 |
| Decision Date | 2015-06-29 |
| Summary: | summary |