FDA 510(k)

标准可灭菌托盘

K号: K202524 · 2021-01-28

申请人Implant Direct Sybron Manufacturing, LLC

决定日期2021-01-28

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

Standard Sterilizable Tray is the device name listed in this FDA 510(k) record. The listed applicant is Implant Direct Sybron Manufacturing, LLC. It received FDA 510(k) clearance on 2021-01-28 under 510(k) number K202524. 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 Standard Sterilizable Tray?

Standard Sterilizable Tray is a medical device that received FDA 510(k) clearance on 2021-01-28. The listed applicant is Implant Direct Sybron Manufacturing, LLC. The 510(k) number is K202524.

When did Standard Sterilizable Tray receive FDA 510(k) clearance?

Standard Sterilizable Tray received FDA 510(k) clearance on 2021-01-28, under 510(k) number K202524.

Who is the listed applicant for Standard Sterilizable Tray?

The FDA 510(k) record lists Implant Direct Sybron Manufacturing, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Standard Sterilizable Tray?

The FDA product code for Standard Sterilizable Tray is KCT.

列明Implant Direct Sybron Manufacturing, LLC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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