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FDA 510(k)

SteriTite 硬质可重复使用消毒容器与 MediTray 产品

K号: K240898 · 2024-07-31

申请人Case Medical
决定日期2024-07-31
产品代码KCT
咨询委员会医疗设备监管文本翻译如下: HO 请注意,由于您没有提供具体的医疗设备监管文本内容,以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同

器械摘要

SteriTite rigid reusable sterilization container with MediTray Products is the device name listed in this FDA 510(k) record. The listed applicant is Case Medical. It received FDA 510(k) clearance on 2024-07-31 under 510(k) number K240898. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SteriTite rigid reusable sterilization container with MediTray Products?

SteriTite rigid reusable sterilization container with MediTray Products is a medical device that received FDA 510(k) clearance on 2024-07-31. The listed applicant is Case Medical. The 510(k) number is K240898.

When did SteriTite rigid reusable sterilization container with MediTray Products receive FDA 510(k) clearance?

SteriTite rigid reusable sterilization container with MediTray Products received FDA 510(k) clearance on 2024-07-31, under 510(k) number K240898.

Who is the listed applicant for SteriTite rigid reusable sterilization container with MediTray Products?

The FDA 510(k) record lists Case Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SteriTite rigid reusable sterilization container with MediTray Products?

The FDA product code for SteriTite rigid reusable sterilization container with MediTray Products is KCT.

相关临床试验

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:KCT)

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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