FDA 510(k)

LifeStyles® SKYN®亲密时刻个人润滑剂

K号: K172473 · 2017-12-15

决定日期2017-12-15

产品代码NUC

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决定实质等同

器械摘要

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.

常见问题

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.

列明Sxwell USA, LLC为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K182438合成聚异丁烯润滑男性避孕套 - 5种感官

官方来源

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