FDA 510(k)

一次性标准钳

K号: K181608 · 2018-09-27

决定日期2018-09-27

产品代码GCJ

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决定实质等同

器械摘要

Disposable 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 2018-09-27 under 510(k) number K181608. 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 Disposable Standard Clamp?

Disposable Standard Clamp is a medical device that received FDA 510(k) clearance on 2018-09-27. The listed applicant is Standard Bariatrics. The 510(k) number is K181608.

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

Disposable Standard Clamp received FDA 510(k) clearance on 2018-09-27, under 510(k) number K181608.

Who is the listed applicant for Disposable 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 Disposable Standard Clamp?

The FDA product code for Disposable 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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