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FDA 510(k)

DMAX著色液；張氏液體；自信著色液；CAMeleon著色液

K 號：K173769 · 2018-03-08

申請人Dmax Co., Ltd.
決定日期2018-03-08
產品代碼EIH
諮詢委員會DE
決定相當於

器材摘要

DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid is the device name listed in this FDA 510(k) record. The listed applicant is Dmax Co., Ltd.. It received FDA 510(k) clearance on 2018-03-08 under 510(k) number K173769. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid?

DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid is a medical device that received FDA 510(k) clearance on 2018-03-08. The listed applicant is Dmax Co., Ltd.. The 510(k) number is K173769.

When did DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid receive FDA 510(k) clearance?

DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid received FDA 510(k) clearance on 2018-03-08, under 510(k) number K173769.

Who is the listed applicant for DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid?

The FDA 510(k) record lists Dmax Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid?

The FDA product code for DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid is EIH.

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其他以 Dmax Co., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K250826多麥系列

相關器械（代碼：EIH）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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