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 |