The following data is part of a premarket notification filed by Genoss Co., Ltd. with the FDA for Rainbow Ls Block.
| Device ID | K160144 |
| 510k Number | K160144 |
| Device Name: | Rainbow LS Block |
| Classification | Powder, Porcelain |
| Applicant | GENOSS CO., LTD. 1F GYEONGGI R&DB CENTER, 105 GWANGGYO-RO, YEONGTONG-GU Suwon-si, KR 16229 |
| Contact | Han Yein |
| Correspondent | Kim Byungsun 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 | 2016-01-21 |
| Decision Date | 2016-07-21 |
| Summary: | summary |