FDA 510(k)

RODIN自然化套件

K号: K223365 · 2023-03-27

决定日期2023-03-27

产品代码EBD

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决定实质等同

器械摘要

RODIN Palette Naturalizing Kit is the device name listed in this FDA 510(k) record. The listed applicant is Belport Company, Inc., Gingi-Pak. It received FDA 510(k) clearance on 2023-03-27 under 510(k) number K223365. The device is classified under product code EBD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the RODIN Palette Naturalizing Kit?

RODIN Palette Naturalizing Kit is a medical device that received FDA 510(k) clearance on 2023-03-27. The listed applicant is Belport Company, Inc., Gingi-Pak. The 510(k) number is K223365.

When did RODIN Palette Naturalizing Kit receive FDA 510(k) clearance?

RODIN Palette Naturalizing Kit received FDA 510(k) clearance on 2023-03-27, under 510(k) number K223365.

Who is the listed applicant for RODIN Palette Naturalizing Kit?

The FDA 510(k) record lists Belport Company, Inc., Gingi-Pak as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RODIN Palette Naturalizing Kit?

The FDA product code for RODIN Palette Naturalizing Kit is EBD.

列明Belport Company, Inc., Gingi-Pak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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