The following data is part of a premarket notification filed by Neosil Co., Ltd with the FDA for Peak Ns033cf, Peak Ns017cf.
| Device ID | K180565 |
| 510k Number | K180565 |
| Device Name: | PEAK NS033CF, PEAK NS017CF |
| Classification | Material, Impression |
| Applicant | Neosil Co., Ltd 63, Gongdanseo-ro 18beon-gil, Geumjeong-gu Gyeongsangnam-do, KR 46332 |
| Contact | Woo-ryong Ryou |
| Correspondent | Yang Ho Dong Onbix Corporation #821 Samil Plaza, 14, Dogok-ro 1-gil, Gangnam-gu Seoul, KR 06523 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-05 |
| Decision Date | 2018-06-13 |
| Summary: | summary |