FDA 510(k)

Triumph 树脂阻尼器

K号: K151945 · 2016-02-18

决定日期2016-02-18

产品代码EIE

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决定实质等同

器械摘要

Triumph Resin Dam is the device name listed in this FDA 510(k) record. The listed applicant is Denali Corporation. It received FDA 510(k) clearance on 2016-02-18 under 510(k) number K151945. The device is classified under product code EIE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Triumph Resin Dam?

Triumph Resin Dam is a medical device that received FDA 510(k) clearance on 2016-02-18. The listed applicant is Denali Corporation. The 510(k) number is K151945.

When did Triumph Resin Dam receive FDA 510(k) clearance?

Triumph Resin Dam received FDA 510(k) clearance on 2016-02-18, under 510(k) number K151945.

Who is the listed applicant for Triumph Resin Dam?

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

What is the FDA product code for Triumph Resin Dam?

The FDA product code for Triumph Resin Dam is EIE.

列明Denali 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。

K153191Calcium Bridge

官方来源

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