FDA 510(k)

合成聚异丁烯润滑男性避孕套 - 5种感官

K号: K182438 · 2018-12-06

决定日期2018-12-06

产品代码MOL

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决定实质等同

器械摘要

Synthetic Polyisoprene Lubricated Male Condom - 5 senses 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 2018-12-06 under 510(k) number K182438. 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 Synthetic Polyisoprene Lubricated Male Condom - 5 senses?

Synthetic Polyisoprene Lubricated Male Condom - 5 senses is a medical device that received FDA 510(k) clearance on 2018-12-06. The listed applicant is Sxwell USA, LLC. The 510(k) number is K182438.

When did Synthetic Polyisoprene Lubricated Male Condom - 5 senses receive FDA 510(k) clearance?

Synthetic Polyisoprene Lubricated Male Condom - 5 senses received FDA 510(k) clearance on 2018-12-06, under 510(k) number K182438.

Who is the listed applicant for Synthetic Polyisoprene Lubricated Male Condom - 5 senses?

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 Synthetic Polyisoprene Lubricated Male Condom - 5 senses?

The FDA product code for Synthetic Polyisoprene Lubricated Male Condom - 5 senses is MOL.

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。

K172473LifeStyles® SKYN®亲密时刻个人润滑剂

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