The following data is part of a premarket notification filed by Saeshin Precision Co., Ltd. with the FDA for Traus Sus20.
| Device ID | K192561 |
| 510k Number | K192561 |
| Device Name: | TRAUS SUS20 |
| Classification | Drill, Bone, Powered |
| Applicant | Saeshin Precision Co., Ltd. 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun Daegu, KR 42921 |
| Contact | Dongha Lee |
| Correspondent | Jong Woo Choi Saeshin Precision Co., Ltd. 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun Daegu, KR 42921 |
| Product Code | DZI |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-17 |
| Decision Date | 2020-07-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809260472174 | K192561 | 000 |
| 08809260472167 | K192561 | 000 |
| 08809260472150 | K192561 | 000 |
| 08809260472143 | K192561 | 000 |