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FDA 510(k)

Artelon Convenience Kits

K号: K260317 · 2026-04-09

决定日期2026-04-09
产品代码QWJ
咨询委员会SU 请注意,您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

Artelon Convenience Kits is the device name listed in this FDA 510(k) record. The listed applicant is International Life Sciences. It received FDA 510(k) clearance on 2026-04-09 under 510(k) number K260317. The device is classified under product code QWJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Artelon Convenience Kits?

Artelon Convenience Kits is a medical device that received FDA 510(k) clearance on 2026-04-09. The listed applicant is International Life Sciences. The 510(k) number is K260317.

When did Artelon Convenience Kits receive FDA 510(k) clearance?

Artelon Convenience Kits received FDA 510(k) clearance on 2026-04-09, under 510(k) number K260317.

Who is the listed applicant for Artelon Convenience Kits?

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

What is the FDA product code for Artelon Convenience Kits?

The FDA product code for Artelon Convenience Kits is QWJ.

相关临床试验

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列明International Life Sciences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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