FDA 510(k)

DERMABOND PRINEO 皮膚閉合系統

K 號：K163645 · 2017-04-21

決定日期2017-04-21

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

DERMABOND PRINEO Skin Closure System is the device name listed in this FDA 510(k) record. The listed applicant is Ethicon, LLC. It received FDA 510(k) clearance on 2017-04-21 under 510(k) number K163645. 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 DERMABOND PRINEO Skin Closure System?

DERMABOND PRINEO Skin Closure System is a medical device that received FDA 510(k) clearance on 2017-04-21. The listed applicant is Ethicon, LLC. The 510(k) number is K163645.

When did DERMABOND PRINEO Skin Closure System receive FDA 510(k) clearance?

DERMABOND PRINEO Skin Closure System received FDA 510(k) clearance on 2017-04-21, under 510(k) number K163645.

Who is the listed applicant for DERMABOND PRINEO Skin Closure System?

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

What is the FDA product code for DERMABOND PRINEO Skin Closure System?

The FDA product code for DERMABOND PRINEO Skin Closure System is OMD.

其他以 Ethicon, LLC 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。

K233460CM00622 LINC 皮膚縫合系統 (CM00622 LINC)Connexicon Medical , Ltd.K211878LiquiBand XLAdvanced Medical Solutions Limited K213512DERMABOND PRINEO 皮膚閉合系統ETHICON, Inc.K191461Exofin 融合皮膚閉合系統Chemence Medical, Inc.K171442Exofin 融合皮膚閉合系統Chemence Medical, Inc.

官方來源

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