FDA 510(k)

同种异体移植物微创输送系统

K号: K201338 · 2020-07-13

决定日期2020-07-13

产品代码FMF

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

Allograft MIS Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Lifenet Health. It received FDA 510(k) clearance on 2020-07-13 under 510(k) number K201338. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Allograft MIS Delivery System?

Allograft MIS Delivery System is a medical device that received FDA 510(k) clearance on 2020-07-13. The listed applicant is Lifenet Health. The 510(k) number is K201338.

When did Allograft MIS Delivery System receive FDA 510(k) clearance?

Allograft MIS Delivery System received FDA 510(k) clearance on 2020-07-13, under 510(k) number K201338.

Who is the listed applicant for Allograft MIS Delivery System?

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

What is the FDA product code for Allograft MIS Delivery System?

The FDA product code for Allograft MIS Delivery System is FMF.

列明Lifenet Health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。

K242799PliaFX Flo

相关器械（代码：FMF）

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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官方来源

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