The following data is part of a premarket notification filed by Saeshin Precision Co., Ltd. with the FDA for Traus Sip10.
| Device ID | K123695 |
| 510k Number | K123695 |
| Device Name: | TRAUS SIP10 |
| Classification | Handpiece, Water-powered |
| Applicant | SAESHIN PRECISION CO., LTD. #93-15, PAHO-DONG, DALSEO-GU Daegu, KR 704-220 |
| Contact | Y.s. Lee |
| Correspondent | Jeffrey D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | EKY |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-12-03 |
| Decision Date | 2012-12-18 |
| Summary: | summary |