FDA 510(k)

良好铅提取袋

K号: K160801 · 2016-11-29

决定日期2016-11-29

产品代码GCJ

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定实质等同

器械摘要

Well Lead Extraction Bag is the device name listed in this FDA 510(k) record. The listed applicant is Well Lead Medical Co., Ltd.. It received FDA 510(k) clearance on 2016-11-29 under 510(k) number K160801. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Well Lead Extraction Bag?

Well Lead Extraction Bag is a medical device that received FDA 510(k) clearance on 2016-11-29. The listed applicant is Well Lead Medical Co., Ltd.. The 510(k) number is K160801.

When did Well Lead Extraction Bag receive FDA 510(k) clearance?

Well Lead Extraction Bag received FDA 510(k) clearance on 2016-11-29, under 510(k) number K160801.

Who is the listed applicant for Well Lead Extraction Bag?

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

What is the FDA product code for Well Lead Extraction Bag?

The FDA product code for Well Lead Extraction Bag is GCJ.

列明Well Lead Medical 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。

K241734Wellead®亲水性间歇导尿管即用型；Wellead®亲水性间歇导尿管紧凑型 K220722PVC 亲水性尿道导管 K220036Wellead 肾盂导管 K211543魏鼻喷管 K211814Wellead 内窥镜密封装置 K202134Well Lead All 硅胶 Foley 导尿管带温度传感器

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相关器械（代码：GCJ）

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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