FDA 510(k)

ePTFE涂层耳部植入物

K号: K172389 · 2018-07-18

决定日期2018-07-18

产品代码FZD

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决定实质等同

器械摘要

ePTFE-Coated Auricular 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 2018-07-18 under 510(k) number K172389. The device is classified under product code FZD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ePTFE-Coated Auricular Implant?

ePTFE-Coated Auricular Implant is a medical device that received FDA 510(k) clearance on 2018-07-18. The listed applicant is Implantech Associates, Inc.. The 510(k) number is K172389.

When did ePTFE-Coated Auricular Implant receive FDA 510(k) clearance?

ePTFE-Coated Auricular Implant received FDA 510(k) clearance on 2018-07-18, under 510(k) number K172389.

Who is the listed applicant for ePTFE-Coated Auricular 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 ePTFE-Coated Auricular Implant?

The FDA product code for ePTFE-Coated Auricular Implant is FZD.

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 K191130定制轮廓植入物

官方来源

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器械摘要

常见问题

相关临床试验

列明Implantech Associates, Inc.为申报人的其他记录

官方来源