FDA 510(k)

Skyn 原版聚异丁烯润滑男性避孕套

K号: K160399 · 2016-07-25

决定日期2016-07-25

产品代码MOL

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决定实质等同

器械摘要

Skyn Original Polyisoprene Lubricated Male Condom is the device name listed in this FDA 510(k) record. The listed applicant is Ansell Healthcare Products, LLC. It received FDA 510(k) clearance on 2016-07-25 under 510(k) number K160399. The device is classified under product code MOL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Skyn Original Polyisoprene Lubricated Male Condom?

Skyn Original Polyisoprene Lubricated Male Condom is a medical device that received FDA 510(k) clearance on 2016-07-25. The listed applicant is Ansell Healthcare Products, LLC. The 510(k) number is K160399.

When did Skyn Original Polyisoprene Lubricated Male Condom receive FDA 510(k) clearance?

Skyn Original Polyisoprene Lubricated Male Condom received FDA 510(k) clearance on 2016-07-25, under 510(k) number K160399.

Who is the listed applicant for Skyn Original Polyisoprene Lubricated Male Condom?

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

What is the FDA product code for Skyn Original Polyisoprene Lubricated Male Condom?

The FDA product code for Skyn Original Polyisoprene Lubricated Male Condom is MOL.

列明Ansell Healthcare Products, 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。

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官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。