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FDA 510(k)

Innomed NPWT 硅胶泡沫敷料

K号: K202823 · 2021-12-15

决定日期2021-12-15
产品代码OMP
咨询委员会SU 请注意,您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

Innomed NPWT Silicone Foam Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Longterm Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-12-15 under 510(k) number K202823. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Innomed NPWT Silicone Foam Dressing?

Innomed NPWT Silicone Foam Dressing is a medical device that received FDA 510(k) clearance on 2021-12-15. The listed applicant is Zhejiang Longterm Medical Technology Co., Ltd.. The 510(k) number is K202823.

When did Innomed NPWT Silicone Foam Dressing receive FDA 510(k) clearance?

Innomed NPWT Silicone Foam Dressing received FDA 510(k) clearance on 2021-12-15, under 510(k) number K202823.

Who is the listed applicant for Innomed NPWT Silicone Foam Dressing?

FDA 510(k)记录将浙江龙泰医疗科技有限公司列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Innomed NPWT Silicone Foam Dressing?

The FDA product code for Innomed NPWT Silicone Foam Dressing is OMP.

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。

列明Zhejiang Longterm Medical Technology Co., Ltd.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:OMP)

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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