The following data is part of a premarket notification filed by Genoss with the FDA for Rainbow Trans.
| Device ID | K151723 |
| 510k Number | K151723 |
| Device Name: | Rainbow Trans |
| Classification | Powder, Porcelain |
| Applicant | GENOSS 105 GWANGGYO-RO, YEONGTONG-GU 1F, GYEONGGI R&DB CENTER / 226, 2F, GSBC Suwon-si, KR 443-270 |
| Contact | Sangpil Yoon |
| Correspondent | Dachan Kwon ICT AMERICA, INC. 180 SYLVAN AVENUE, 2ND FLOOR Englewood Cliffs, NJ 07632 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-26 |
| Decision Date | 2015-10-28 |
| Summary: | summary |