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FDA 510(k)

定制

K号: K213779 · 2022-03-16

申请人3D-Side S.A.
决定日期2022-03-16
产品代码QIH
咨询委员会RA
决定实质等同

器械摘要

Customize is the device name listed in this FDA 510(k) record. The listed applicant is 3D-Side S.A.. It received FDA 510(k) clearance on 2022-03-16 under 510(k) number K213779. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Customize?

Customize is a medical device that received FDA 510(k) clearance on 2022-03-16. The listed applicant is 3D-Side S.A.. The 510(k) number is K213779.

When did Customize receive FDA 510(k) clearance?

Customize received FDA 510(k) clearance on 2022-03-16, under 510(k) number K213779.

Who is the listed applicant for Customize?

The FDA 510(k) record lists 3D-Side S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Customize?

The FDA product code for Customize is QIH.

相关临床试验

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列明3D-Side S.A.为申报人的其他记录

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相关器械(代码:QIH)

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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