FDA 510(k)

RODIN 3D树脂夹板，硬/软

K号: K231793 · 2024-03-26

决定日期2024-03-26

产品代码MQC

决定实质等同

器械摘要

RODIN 3D Resin SPLINT, Hard/Flex 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 2024-03-26 under 510(k) number K231793. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

常见问题

What is the RODIN 3D Resin SPLINT, Hard/Flex?

RODIN 3D Resin SPLINT, Hard/Flex is a medical device that received FDA 510(k) clearance on 2024-03-26. The listed applicant is Belport Company, Inc., Gingi-Pak. The 510(k) number is K231793.

When did RODIN 3D Resin SPLINT, Hard/Flex receive FDA 510(k) clearance?

RODIN 3D Resin SPLINT, Hard/Flex received FDA 510(k) clearance on 2024-03-26, under 510(k) number K231793.

Who is the listed applicant for RODIN 3D Resin SPLINT, Hard/Flex?

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 3D Resin SPLINT, Hard/Flex?

The FDA product code for RODIN 3D Resin SPLINT, Hard/Flex is MQC.

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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