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FDA 510(k)

VarseoSmile TriniQ

K号: K233596 · 2023-11-09

决定日期2023-11-09
产品代码EBF
咨询委员会DE 请注意,您没有提供具体的医疗设备监管文本内容,因此我无法进行翻译。请提供需要翻译的具体文本,我将根据您的要求进行翻译。
决定实质等同

器械摘要

VarseoSmile TriniQ is the device name listed in this FDA 510(k) record. The listed applicant is Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG. It received FDA 510(k) clearance on 2023-11-09 under 510(k) number K233596. 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 VarseoSmile TriniQ?

VarseoSmile TriniQ is a medical device that received FDA 510(k) clearance on 2023-11-09. The listed applicant is Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG. The 510(k) number is K233596.

When did VarseoSmile TriniQ receive FDA 510(k) clearance?

VarseoSmile TriniQ received FDA 510(k) clearance on 2023-11-09, under 510(k) number K233596.

Who is the listed applicant for VarseoSmile TriniQ?

The FDA 510(k) record lists Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VarseoSmile TriniQ?

The FDA product code for VarseoSmile TriniQ is EBF.

相关临床试验

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列明Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG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。

相关器械(代码:EBF)

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。

官方来源

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