FDA 510(k)

CM00622 LINC 皮膚縫合系統 (CM00622 LINC)

K 號：K233460 · 2024-07-15

決定日期2024-07-15

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

CM00622 LINC Skin Closure System (CM00622 LINC) is the device name listed in this FDA 510(k) record. The listed applicant is Connexicon Medical , Ltd.. It received FDA 510(k) clearance on 2024-07-15 under 510(k) number K233460. 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 CM00622 LINC Skin Closure System (CM00622 LINC)?

CM00622 LINC Skin Closure System (CM00622 LINC) is a medical device that received FDA 510(k) clearance on 2024-07-15. The listed applicant is Connexicon Medical , Ltd.. The 510(k) number is K233460.

When did CM00622 LINC Skin Closure System (CM00622 LINC) receive FDA 510(k) clearance?

CM00622 LINC Skin Closure System (CM00622 LINC) received FDA 510(k) clearance on 2024-07-15, under 510(k) number K233460.

Who is the listed applicant for CM00622 LINC Skin Closure System (CM00622 LINC)?

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

What is the FDA product code for CM00622 LINC Skin Closure System (CM00622 LINC)?

The FDA product code for CM00622 LINC Skin Closure System (CM00622 LINC) is OMD.

其他以 Connexicon Medical , Ltd. 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。

K233458CM005標準型 (CM005)；CM004迷你型 (CM004)

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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