FDA 510(k)

Exofin 融合皮肤闭合系统

K号: K191461 · 2020-06-05

决定日期2020-06-05

产品代码OMD

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决定实质等同

器械摘要

Exofin Fusion Skin Closure System is the device name listed in this FDA 510(k) record. The listed applicant is Chemence Medical, Inc.. It received FDA 510(k) clearance on 2020-06-05 under 510(k) number K191461. The device is classified under product code OMD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Exofin Fusion Skin Closure System?

Exofin Fusion Skin Closure System is a medical device that received FDA 510(k) clearance on 2020-06-05. The listed applicant is Chemence Medical, Inc.. The 510(k) number is K191461.

When did Exofin Fusion Skin Closure System receive FDA 510(k) clearance?

Exofin Fusion Skin Closure System received FDA 510(k) clearance on 2020-06-05, under 510(k) number K191461.

Who is the listed applicant for Exofin Fusion Skin Closure System?

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

What is the FDA product code for Exofin Fusion Skin Closure System?

The FDA product code for Exofin Fusion Skin Closure System is OMD.

列明Chemence Medical, 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。

K212246Exofin 精密笔 K200264Exofin 高粘度局部皮肤粘合剂 K171442Exofin 融合皮肤闭合系统 K162352derma+flex QS 高粘度组织粘合剂

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