The following data is part of a premarket notification filed by Gni Co., Ltd with the FDA for Rosa Bracket.
| Device ID | K182672 |
| 510k Number | K182672 |
| Device Name: | ROSA Bracket |
| Classification | Bracket, Ceramic, Orthodontic |
| Applicant | GNI Co., LTD 5F 501, 63-12 Dongtancheomdansaneop 1-RO Hwaseong, KR 18469 |
| Contact | Duk Soo Kim |
| Correspondent | Sang Hwa Myung E&M Consulting D-1474ho, 230 Simin-daero, Dongan-gu Anyang, KR 14067 |
| Product Code | NJM |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-26 |
| Decision Date | 2019-11-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800046017626 | K182672 | 000 |