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FDA 510(k)

Onetouch 非对羟基苯甲酸酯润滑凝胶

K号: K220273 · 2022-10-21

决定日期2022-10-21
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

Onetouch Non-paraben Lubricant Gel is the device name listed in this FDA 510(k) record. The listed applicant is Thai Nippon Rubber Industry Public Company Limited.. It received FDA 510(k) clearance on 2022-10-21 under 510(k) number K220273. 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 Onetouch Non-paraben Lubricant Gel?

Onetouch Non-paraben Lubricant Gel is a medical device that received FDA 510(k) clearance on 2022-10-21. The listed applicant is Thai Nippon Rubber Industry Public Company Limited.. The 510(k) number is K220273.

When did Onetouch Non-paraben Lubricant Gel receive FDA 510(k) clearance?

Onetouch Non-paraben Lubricant Gel received FDA 510(k) clearance on 2022-10-21, under 510(k) number K220273.

Who is the listed applicant for Onetouch Non-paraben Lubricant Gel?

The FDA 510(k) record lists Thai Nippon Rubber Industry Public Company Limited. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Onetouch Non-paraben Lubricant Gel?

The FDA product code for Onetouch Non-paraben Lubricant Gel is NUC.

相关临床试验

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列明Thai Nippon Rubber Industry Public Company Limited.为申报人的其他记录

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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。

官方来源

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