FDA 510(k)

StarPore

K号: K200532 · 2020-06-02

决定日期2020-06-02

产品代码JOF

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决定实质等同

器械摘要

StarPore is the device name listed in this FDA 510(k) record. The listed applicant is Anatomics Pty, Ltd.. It received FDA 510(k) clearance on 2020-06-02 under 510(k) number K200532. The device is classified under product code JOF. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the StarPore?

StarPore is a medical device that received FDA 510(k) clearance on 2020-06-02. The listed applicant is Anatomics Pty, Ltd.. The 510(k) number is K200532.

When did StarPore receive FDA 510(k) clearance?

StarPore received FDA 510(k) clearance on 2020-06-02, under 510(k) number K200532.

Who is the listed applicant for StarPore?

The FDA 510(k) record lists Anatomics Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for StarPore?

The FDA product code for StarPore is JOF.

列明Anatomics Pty, Ltd.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。

K171037PoreStar患者特异性植入物

官方来源

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