FDA 510(k)

JO H2O 莲蓉原味个人润滑剂

K号: K183584 · 2019-04-17

决定日期2019-04-17

产品代码NUC

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决定实质等同

器械摘要

JO H2O Jelly Original Personal Lubricant is the device name listed in this FDA 510(k) record. The listed applicant is United Consortium. It received FDA 510(k) clearance on 2019-04-17 under 510(k) number K183584. 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 JO H2O Jelly Original Personal Lubricant?

JO H2O Jelly Original Personal Lubricant is a medical device that received FDA 510(k) clearance on 2019-04-17. The listed applicant is United Consortium. The 510(k) number is K183584.

When did JO H2O Jelly Original Personal Lubricant receive FDA 510(k) clearance?

JO H2O Jelly Original Personal Lubricant received FDA 510(k) clearance on 2019-04-17, under 510(k) number K183584.

Who is the listed applicant for JO H2O Jelly Original Personal Lubricant?

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

What is the FDA product code for JO H2O Jelly Original Personal Lubricant?

The FDA product code for JO H2O Jelly Original Personal Lubricant is NUC.

列明United Consortium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。

K192203JO for Him H2O凝胶原液个人润滑剂 K190858Bucked Stride 硅胶润滑剂，#LubeLife 薄硅胶润滑剂，JO XTRA SILKY 超薄硅胶个人润滑剂 K191214JO 预级凝胶原味个人润滑剂 K182585JO 主动尝试个人润滑剂 K183384JO Agape 原始个人润滑剂，MUSE 精华水基润滑剂，#LubeLife 水基润滑剂，#LubeLife 水基肛门润滑剂 K182105JO Naturalove 个人润滑剂，JO Naturalove 草莓园口味个人润滑剂

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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。