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FDA 510(k)

Smith & Nephew 药片应用

K号: K190367 · 2019-05-21

决定日期2019-05-21
产品代码QGY
咨询委员会GU 请注意,由于您只提供了“GU”这个词,我无法提供完整的翻译。如果您能提供完整的句子或段落,我将能够为您提供准确的翻译。
决定实质等同

器械摘要

Smith & Nephew Tablet Application is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew. It received FDA 510(k) clearance on 2019-05-21 under 510(k) number K190367. The device is classified under product code QGY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Smith & Nephew Tablet Application?

Smith & Nephew Tablet Application is a medical device that received FDA 510(k) clearance on 2019-05-21. The listed applicant is Smith & Nephew. The 510(k) number is K190367.

When did Smith & Nephew Tablet Application receive FDA 510(k) clearance?

Smith & Nephew Tablet Application received FDA 510(k) clearance on 2019-05-21, under 510(k) number K190367.

Who is the listed applicant for Smith & Nephew Tablet Application?

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

What is the FDA product code for Smith & Nephew Tablet Application?

The FDA product code for Smith & Nephew Tablet Application is QGY.

相关临床试验

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列明Smith & Nephew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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