The following data is part of a premarket notification filed by Saeshin Precision Co., Ltd. with the FDA for Traus Sip20.
| Device ID | K201292 |
| 510k Number | K201292 |
| Device Name: | TRAUS SIP20 |
| Classification | Controller, Foot, Handpiece And Cord |
| Applicant | Saeshin Precision Co., Ltd. 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun Daegu, KR 42921 |
| Contact | Gungsan Nam |
| Correspondent | Dongha Lee KMC, Inc. Room No. 904, 27, Digital-ro 27ga-gil, Guro-gu Seoul, KR 08375 |
| Product Code | EBW |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-14 |
| Decision Date | 2021-02-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809260472181 | K201292 | 000 |
| 08809260471689 | K201292 | 000 |