FDA 510(k)

パッションナチュラルウォーターベースルブリケーション

K番号: K202017 · 2021-01-08

決定日2021-01-08

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

Passion Natural Water Based Lubricant is the device name listed in this FDA 510(k) record. The listed applicant is Xr, LLC. It received FDA 510(k) clearance on 2021-01-08 under 510(k) number K202017. 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 Passion Natural Water Based Lubricant?

Passion Natural Water Based Lubricant is a medical device that received FDA 510(k) clearance on 2021-01-08. The listed applicant is Xr, LLC. The 510(k) number is K202017.

When did Passion Natural Water Based Lubricant receive FDA 510(k) clearance?

Passion Natural Water Based Lubricant received FDA 510(k) clearance on 2021-01-08, under 510(k) number K202017.

Who is the listed applicant for Passion Natural Water Based Lubricant?

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

What is the FDA product code for Passion Natural Water Based Lubricant?

The FDA product code for Passion Natural Water Based Lubricant is NUC.

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パッションナチュラルウォーターベースルブリケーション

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）

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