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FDA 510(k)

SURECELL 凝胶纤维伤口敷料

K号: K173005 · 2018-05-25

决定日期2018-05-25
产品代码KGN
决定实质等同

器械摘要

SURECELL Gelling Fiber Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Newvalue Medical Producst Co.,Ltd. It received FDA 510(k) clearance on 2018-05-25 under 510(k) number K173005. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常见问题

What is the SURECELL Gelling Fiber Wound Dressing?

SURECELL Gelling Fiber Wound Dressing is a medical device that received FDA 510(k) clearance on 2018-05-25. The listed applicant is Jiangsu Newvalue Medical Producst Co.,Ltd. The 510(k) number is K173005.

When did SURECELL Gelling Fiber Wound Dressing receive FDA 510(k) clearance?

SURECELL Gelling Fiber Wound Dressing received FDA 510(k) clearance on 2018-05-25, under 510(k) number K173005.

Who is the listed applicant for SURECELL Gelling Fiber Wound Dressing?

The FDA 510(k) record lists Jiangsu Newvalue Medical Producst Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURECELL Gelling Fiber Wound Dressing?

The FDA product code for SURECELL Gelling Fiber Wound Dressing is KGN.

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。

相关器械(代码:KGN)

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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