FDA 510(k)

Exofin 融合皮膚閉合系統

K 號：K191461 · 2020-06-05

決定日期2020-06-05

產品代碼OMD

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

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.

常見問題

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.

其他以 Chemence Medical, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：OMD）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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