FDA 510(k)

单次使用外科吸引冲洗器

K号: K161421 · 2016-06-24

申请人Jiangsu Haize Medical Scientific Development Co., Ltd.

决定日期2016-06-24

产品代码GCJ

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决定实质等同

器械摘要

Single Use Surgical Suction Irrigator is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Haize Medical Scientific Development Co., Ltd.. It received FDA 510(k) clearance on 2016-06-24 under 510(k) number K161421. 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 Single Use Surgical Suction Irrigator?

Single Use Surgical Suction Irrigator is a medical device that received FDA 510(k) clearance on 2016-06-24. The listed applicant is Jiangsu Haize Medical Scientific Development Co., Ltd.. The 510(k) number is K161421.

When did Single Use Surgical Suction Irrigator receive FDA 510(k) clearance?

Single Use Surgical Suction Irrigator received FDA 510(k) clearance on 2016-06-24, under 510(k) number K161421.

Who is the listed applicant for Single Use Surgical Suction Irrigator?

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

What is the FDA product code for Single Use Surgical Suction Irrigator?

The FDA product code for Single Use Surgical Suction Irrigator is GCJ.

列明Jiangsu Haize Medical Scientific Development 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。

K230593维克坦

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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