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FDA 510(k)

再生处理ArthroCare耳鼻喉科电凝器

K号: K172647 · 2018-02-21

申请人Renovo, Inc.
决定日期2018-02-21
产品代码NUJ
咨询委员会SU 请注意,您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

Reprocessed ArthroCare ENT Coblator is the device name listed in this FDA 510(k) record. The listed applicant is Renovo, Inc.. It received FDA 510(k) clearance on 2018-02-21 under 510(k) number K172647. The device is classified under product code NUJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Reprocessed ArthroCare ENT Coblator?

Reprocessed ArthroCare ENT Coblator is a medical device that received FDA 510(k) clearance on 2018-02-21. The listed applicant is Renovo, Inc.. The 510(k) number is K172647.

When did Reprocessed ArthroCare ENT Coblator receive FDA 510(k) clearance?

Reprocessed ArthroCare ENT Coblator received FDA 510(k) clearance on 2018-02-21, under 510(k) number K172647.

Who is the listed applicant for Reprocessed ArthroCare ENT Coblator?

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

What is the FDA product code for Reprocessed ArthroCare ENT Coblator?

The FDA product code for Reprocessed ArthroCare ENT Coblator is NUJ.

相关临床试验

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列明Renovo, Inc.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。

相关器械(代码:NUJ)

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。

官方来源

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