FDA 510(k)

Parietene Macroporous 网格

K号: K223218 · 2022-12-02

决定日期2022-12-02

产品代码FTL

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决定实质等同

器械摘要

Parietene Macroporous Mesh is the device name listed in this FDA 510(k) record. The listed applicant is Sofradim Production. It received FDA 510(k) clearance on 2022-12-02 under 510(k) number K223218. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Parietene Macroporous Mesh?

Parietene Macroporous Mesh is a medical device that received FDA 510(k) clearance on 2022-12-02. The listed applicant is Sofradim Production. The 510(k) number is K223218.

When did Parietene Macroporous Mesh receive FDA 510(k) clearance?

Parietene Macroporous Mesh received FDA 510(k) clearance on 2022-12-02, under 510(k) number K223218.

Who is the listed applicant for Parietene Macroporous Mesh?

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

What is the FDA product code for Parietene Macroporous Mesh?

The FDA product code for Parietene Macroporous Mesh is FTL.

列明Sofradim Production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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官方来源

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