The following data is part of a premarket notification filed by Genoss Co. Ltd. with the FDA for Tn-brush.
| Device ID | K170596 |
| 510k Number | K170596 |
| Device Name: | TN-Brush |
| Classification | Scaler, Rotary |
| Applicant | GENOSS Co. Ltd. 1F, Gyeonggi R&DB Center, 105 Gwanggyo-ro, Yeongton-gu, Suwon-si Suwon-si, KR 443-270 |
| Contact | Hyeyoung Moon |
| Correspondent | Hyeyoung Moon GENOSS Co. Ltd. 1F, Gyeonggi R&DB Center, 105 Gwanggyo-ro, Yeongton-gu, Suwon-si Suwon-si, KR 443-270 |
| Product Code | ELB |
| CFR Regulation Number | 872.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-28 |
| Decision Date | 2017-09-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809552960600 | K170596 | 000 |
| 08809552960594 | K170596 | 000 |