FDA 510(k)

Zircos-Com

K号: K190139 · 2020-04-24

决定日期2020-04-24

产品代码EBF

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决定实质等同

器械摘要

Zircos-Com is the device name listed in this FDA 510(k) record. The listed applicant is Bioden Co., Ltd.. It received FDA 510(k) clearance on 2020-04-24 under 510(k) number K190139. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Zircos-Com?

Zircos-Com is a medical device that received FDA 510(k) clearance on 2020-04-24. The listed applicant is Bioden Co., Ltd.. The 510(k) number is K190139.

When did Zircos-Com receive FDA 510(k) clearance?

Zircos-Com received FDA 510(k) clearance on 2020-04-24, under 510(k) number K190139.

Who is the listed applicant for Zircos-Com?

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

What is the FDA product code for Zircos-Com?

The FDA product code for Zircos-Com is EBF.

列明Bioden Co., 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。

K201492非灭菌氧化锆块

官方来源

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