The following data is part of a premarket notification filed by Genoss with the FDA for Rainbow Shade.
| Device ID | K151844 |
| 510k Number | K151844 |
| Device Name: | Rainbow Shade |
| Classification | Powder, Porcelain |
| Applicant | GENOSS 105 GYEONGGI-RO, YEONGTONG-GU 1F, GYEONGGI R&DB CENTER / 226 2F, GSBC Suwon-si, KR 443-270 |
| Contact | Byungsun Kim |
| Correspondent | Dachan Kwon iCT America, Inc. 180 Sylvan Ave., 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 | 2015-07-07 |
| Decision Date | 2015-10-16 |
| Summary: | summary |