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FDA 510(k)

Natureplex 温暖触感加热凝胶

K号: K180828 · 2018-12-20

决定日期2018-12-20
产品代码NUC
咨询委员会OB 请注意,由于您没有提供具体的医疗设备监管文本,我无法进行翻译。请提供具体的文本内容,以便我能够按照您的要求进行翻译。
决定实质等同

器械摘要

Natureplex Warm Touch Warming Jelly is the device name listed in this FDA 510(k) record. The listed applicant is Natureplex, LLC. It received FDA 510(k) clearance on 2018-12-20 under 510(k) number K180828. 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 Natureplex Warm Touch Warming Jelly?

Natureplex Warm Touch Warming Jelly is a medical device that received FDA 510(k) clearance on 2018-12-20. The listed applicant is Natureplex, LLC. The 510(k) number is K180828.

When did Natureplex Warm Touch Warming Jelly receive FDA 510(k) clearance?

Natureplex Warm Touch Warming Jelly received FDA 510(k) clearance on 2018-12-20, under 510(k) number K180828.

Who is the listed applicant for Natureplex Warm Touch Warming Jelly?

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

What is the FDA product code for Natureplex Warm Touch Warming Jelly?

The FDA product code for Natureplex Warm Touch Warming Jelly is NUC.

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相关器械(代码:NUC)

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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