The following data is part of a premarket notification filed by Dmax Co., Ltd. with the FDA for Dmax Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; Cameleon Coloring Liquid.
| Device ID | K173769 |
| 510k Number | K173769 |
| Device Name: | DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid |
| Classification | Powder, Porcelain |
| Applicant | DMAX CO., LTD. 37-26, Dasa-ro 71-gil, Dasa-eup, Dalseong-gun Daegu, KR 42907 |
| Contact | Hyeon Seok Cho |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 690 Roosevelt Irvine, CA 92620 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-11 |
| Decision Date | 2018-03-08 |
| Summary: | summary |