FDA 510(k)

定制轮廓植入物

K号: K191130 · 2019-08-23

决定日期2019-08-23

产品代码FWP

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决定实质等同

器械摘要

Customized Contour Implant is the device name listed in this FDA 510(k) record. The listed applicant is Implantech Associates, Inc.. It received FDA 510(k) clearance on 2019-08-23 under 510(k) number K191130. The device is classified under product code FWP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Customized Contour Implant?

Customized Contour Implant is a medical device that received FDA 510(k) clearance on 2019-08-23. The listed applicant is Implantech Associates, Inc.. The 510(k) number is K191130.

When did Customized Contour Implant receive FDA 510(k) clearance?

Customized Contour Implant received FDA 510(k) clearance on 2019-08-23, under 510(k) number K191130.

Who is the listed applicant for Customized Contour Implant?

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

What is the FDA product code for Customized Contour Implant?

The FDA product code for Customized Contour Implant is FWP.

列明Implantech Associates, 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。

K200610定制轮廓植入物 K172389ePTFE涂层耳部植入物

官方来源

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