FDA 510(k)

ライフスタイルズ® SKYN® イントイマート・モーメンツパーソナル・ルブリケント

K番号: K172473 · 2017-12-15

決定日2017-12-15

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

LifeStyles® SKYN® Intimate Moments Personal Lubricant is the device name listed in this FDA 510(k) record. The listed applicant is Sxwell USA, LLC. It received FDA 510(k) clearance on 2017-12-15 under 510(k) number K172473. 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 LifeStyles® SKYN® Intimate Moments Personal Lubricant?

LifeStyles® SKYN® Intimate Moments Personal Lubricant is a medical device that received FDA 510(k) clearance on 2017-12-15. The listed applicant is Sxwell USA, LLC. The 510(k) number is K172473.

When did LifeStyles® SKYN® Intimate Moments Personal Lubricant receive FDA 510(k) clearance?

LifeStyles® SKYN® Intimate Moments Personal Lubricant received FDA 510(k) clearance on 2017-12-15, under 510(k) number K172473.

Who is the listed applicant for LifeStyles® SKYN® Intimate Moments Personal Lubricant?

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

What is the FDA product code for LifeStyles® SKYN® Intimate Moments Personal Lubricant?

The FDA product code for LifeStyles® SKYN® Intimate Moments Personal Lubricant is NUC.

申請者としてSxwell USA, LLCを記載するその他の記録

K182438合成ポリイソプレン潤滑男性コンドーム - 5つの感覚

公式ソース

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