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FDA 510(k)

3 ml Luer-Jack Slip,5 ml Luer-Jack Slip,20 ml Luer-Jack Slip,10 ml Luer-Jack Lock

K号: K171805 · 2017-09-08

决定日期2017-09-08
产品代码FMF
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

Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml is the device name listed in this FDA 510(k) record. The listed applicant is Conceptomed AS. It received FDA 510(k) clearance on 2017-09-08 under 510(k) number K171805. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml?

Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml is a medical device that received FDA 510(k) clearance on 2017-09-08. The listed applicant is Conceptomed AS. The 510(k) number is K171805.

When did Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml receive FDA 510(k) clearance?

Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml received FDA 510(k) clearance on 2017-09-08, under 510(k) number K171805.

Who is the listed applicant for Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml?

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

What is the FDA product code for Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml?

The FDA product code for Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml is FMF.

列明Conceptomed AS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:FMF)

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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