The following data is part of a premarket notification filed by Saeshin Precision Co., Ltd. with the FDA for Traus Sus10.
| Device ID | K151171 |
| 510k Number | K151171 |
| Device Name: | TRAUS SUS10 |
| Classification | Drill, Bone, Powered |
| Applicant | SAESHIN PRECISION CO., LTD. 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun Daegu, KR 711-814 |
| Contact | Sae Kwan Choi |
| Correspondent | Sae Kwan Choi SAESHIN PRECISION CO., LTD. 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun Daegu, KR 711-814 |
| Product Code | DZI |
| Subsequent Product Code | EBW |
| Subsequent Product Code | EGS |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-01 |
| Decision Date | 2015-09-01 |
| Summary: | summary |