FDA 510(k)

标准夹子

K号: K161720 · 2016-10-24

决定日期2016-10-24

产品代码GCJ

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决定实质等同

器械摘要

Standard Clamp is the device name listed in this FDA 510(k) record. The listed applicant is Standard Bariatrics. It received FDA 510(k) clearance on 2016-10-24 under 510(k) number K161720. 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 Standard Clamp?

Standard Clamp is a medical device that received FDA 510(k) clearance on 2016-10-24. The listed applicant is Standard Bariatrics. The 510(k) number is K161720.

When did Standard Clamp receive FDA 510(k) clearance?

Standard Clamp received FDA 510(k) clearance on 2016-10-24, under 510(k) number K161720.

Who is the listed applicant for Standard Clamp?

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

What is the FDA product code for Standard Clamp?

The FDA product code for Standard Clamp is GCJ.

列明Standard Bariatrics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。

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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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