FDA 510(k)

外部保湿ゲル

K番号: K171855 · 2017-07-21

決定日2017-07-21

製品コードNUC

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OB [翻訳] OB

決定大幅同等

医療機器の概要

External Moisturizing Gel is the device name listed in this FDA 510(k) record. The listed applicant is Combe Incorporated. It received FDA 510(k) clearance on 2017-07-21 under 510(k) number K171855. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the External Moisturizing Gel?

External Moisturizing Gel is a medical device that received FDA 510(k) clearance on 2017-07-21. The listed applicant is Combe Incorporated. The 510(k) number is K171855.

When did External Moisturizing Gel receive FDA 510(k) clearance?

External Moisturizing Gel received FDA 510(k) clearance on 2017-07-21, under 510(k) number K171855.

Who is the listed applicant for External Moisturizing Gel?

The FDA 510(k) record lists Combe Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for External Moisturizing Gel?

The FDA product code for External Moisturizing Gel is NUC.

公式ソース

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。

外部保湿ゲル

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：NUC）

公式ソース