FDA 510(k)

エレガント 2 in 1 ヴァジナルモイストライザー、エレガント・アドバンスド5

K番号: K201612 · 2021-09-02

決定日2021-09-02

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

Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5 is the device name listed in this FDA 510(k) record. The listed applicant is Viramal Limited. It received FDA 510(k) clearance on 2021-09-02 under 510(k) number K201612. 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 Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5?

Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5 is a medical device that received FDA 510(k) clearance on 2021-09-02. The listed applicant is Viramal Limited. The 510(k) number is K201612.

When did Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5 receive FDA 510(k) clearance?

Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5 received FDA 510(k) clearance on 2021-09-02, under 510(k) number K201612.

Who is the listed applicant for Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5?

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

What is the FDA product code for Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5?

The FDA product code for Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5 is NUC.

申請者としてViramal Limitedを記載するその他の記録

K231794エレガント™ アドバンスドコンプホート

公式ソース

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