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FDA 510(k)

Tao 刷 I.U.M.C. 子宫内膜取样器

K号: K170603 · 2017-05-24

决定日期2017-05-24
产品代码HFE
咨询委员会OB 请注意,由于您没有提供具体的医疗设备监管文本,我无法进行翻译。请提供具体的文本内容,以便我能够按照您的要求进行翻译。
决定实质等同

器械摘要

Tao Brush I.U.M.C. Endometrial Sampler is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2017-05-24 under 510(k) number K170603. The device is classified under product code HFE. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Tao Brush I.U.M.C. Endometrial Sampler?

Tao Brush I.U.M.C. Endometrial Sampler is a medical device that received FDA 510(k) clearance on 2017-05-24. The listed applicant is Cook Incorporated. The 510(k) number is K170603.

When did Tao Brush I.U.M.C. Endometrial Sampler receive FDA 510(k) clearance?

Tao Brush I.U.M.C. Endometrial Sampler received FDA 510(k) clearance on 2017-05-24, under 510(k) number K170603.

Who is the listed applicant for Tao Brush I.U.M.C. Endometrial Sampler?

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

What is the FDA product code for Tao Brush I.U.M.C. Endometrial Sampler?

The FDA product code for Tao Brush I.U.M.C. Endometrial Sampler is HFE.

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列明Cook Incorporated为申报人的其他记录

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相关器械(代码:HFE)

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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