FDA 510(k)

Paragon T2 手持式带集成电缆

K号: K153675 · 2016-01-15

决定日期2016-01-15

产品代码GEI

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决定实质等同

器械摘要

Paragon T2 Wand with Integrated Cable is the device name listed in this FDA 510(k) record. The listed applicant is ArthroCare Corporation. It received FDA 510(k) clearance on 2016-01-15 under 510(k) number K153675. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Paragon T2 Wand with Integrated Cable?

Paragon T2 Wand with Integrated Cable is a medical device that received FDA 510(k) clearance on 2016-01-15. The listed applicant is ArthroCare Corporation. The 510(k) number is K153675.

When did Paragon T2 Wand with Integrated Cable receive FDA 510(k) clearance?

Paragon T2 Wand with Integrated Cable received FDA 510(k) clearance on 2016-01-15, under 510(k) number K153675.

Who is the listed applicant for Paragon T2 Wand with Integrated Cable?

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

What is the FDA product code for Paragon T2 Wand with Integrated Cable?

The FDA product code for Paragon T2 Wand with Integrated Cable is GEI.

列明ArthroCare Corporation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：GEI）

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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