FDA 510(k)

Hi-Bond Universal

K号: K230465 · 2023-05-22

决定日期2023-05-22

产品代码KLE

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决定实质等同

器械摘要

Hi-Bond Universal is the device name listed in this FDA 510(k) record. The listed applicant is Mediclus Co., Ltd.. It received FDA 510(k) clearance on 2023-05-22 under 510(k) number K230465. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Hi-Bond Universal?

Hi-Bond Universal is a medical device that received FDA 510(k) clearance on 2023-05-22. The listed applicant is Mediclus Co., Ltd.. The 510(k) number is K230465.

When did Hi-Bond Universal receive FDA 510(k) clearance?

Hi-Bond Universal received FDA 510(k) clearance on 2023-05-22, under 510(k) number K230465.

Who is the listed applicant for Hi-Bond Universal?

FDA 510(k)记录将Mediclus Co., Ltd.列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Hi-Bond Universal?

The FDA product code for Hi-Bond Universal is KLE.

列明Mediclus 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。

K262074任何-Zircos K254201Any-Cem K261728一菲尔LC K260485Any-Etch K260819Any-Com 密封 K253797One-Stop

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