FDA 510(k)

Straumann 外科托盘

K号: K203753 · 2021-07-29

决定日期2021-07-29

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

Straumann Surgical Cassettes is the device name listed in this FDA 510(k) record. The listed applicant is Straumann USA, LLC. It received FDA 510(k) clearance on 2021-07-29 under 510(k) number K203753. 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 Straumann Surgical Cassettes?

Straumann Surgical Cassettes is a medical device that received FDA 510(k) clearance on 2021-07-29. The listed applicant is Straumann USA, LLC. The 510(k) number is K203753.

When did Straumann Surgical Cassettes receive FDA 510(k) clearance?

Straumann Surgical Cassettes received FDA 510(k) clearance on 2021-07-29, under 510(k) number K203753.

Who is the listed applicant for Straumann Surgical Cassettes?

The FDA 510(k) record lists Straumann USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Straumann Surgical Cassettes?

The FDA product code for Straumann Surgical Cassettes is KCT.

列明Straumann USA, 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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官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。