FDA 510(k)

引导手术套件箱

K号: K241492 · 2024-08-23

申请人JJGC Indústria e Comércio de Materiais Dentários S.A.

决定日期2024-08-23

产品代码KCT

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

Guided Surgery Kit Cases is the device name listed in this FDA 510(k) record. The listed applicant is JJGC Indústria e Comércio de Materiais Dentários S.A.. It received FDA 510(k) clearance on 2024-08-23 under 510(k) number K241492. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Guided Surgery Kit Cases?

Guided Surgery Kit Cases is a medical device that received FDA 510(k) clearance on 2024-08-23. The listed applicant is JJGC Indústria e Comércio de Materiais Dentários S.A.. The 510(k) number is K241492.

When did Guided Surgery Kit Cases receive FDA 510(k) clearance?

Guided Surgery Kit Cases received FDA 510(k) clearance on 2024-08-23, under 510(k) number K241492.

Who is the listed applicant for Guided Surgery Kit Cases?

The FDA 510(k) record lists JJGC Indústria e Comércio de Materiais Dentários S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Guided Surgery Kit Cases?

The FDA product code for Guided Surgery Kit Cases is KCT.

列明JJGC Indústria e Comércio de Materiais Dentários S.A.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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