FDA 510(k)

Cook 810 Set, Desilets-Hoffman 引导器套装

K号: K180028 · 2018-05-02

决定日期2018-05-02

产品代码EZN

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

Cook 810 Set, Desilets-Hoffman Introducer Set is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2018-05-02 under 510(k) number K180028. The device is classified under product code EZN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Cook 810 Set, Desilets-Hoffman Introducer Set?

Cook 810 Set, Desilets-Hoffman Introducer Set is a medical device that received FDA 510(k) clearance on 2018-05-02. The listed applicant is Cook Incorporated. The 510(k) number is K180028.

When did Cook 810 Set, Desilets-Hoffman Introducer Set receive FDA 510(k) clearance?

Cook 810 Set, Desilets-Hoffman Introducer Set received FDA 510(k) clearance on 2018-05-02, under 510(k) number K180028.

Who is the listed applicant for Cook 810 Set, Desilets-Hoffman Introducer Set?

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

What is the FDA product code for Cook 810 Set, Desilets-Hoffman Introducer Set?

The FDA product code for Cook 810 Set, Desilets-Hoffman Introducer Set is EZN.

列明Cook Incorporated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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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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