FDA 510(k)

CM00622 LINC 皮肤闭合系统 (CM00622 LINC)

K号: K233460 · 2024-07-15

决定日期2024-07-15

产品代码OMD

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决定实质等同

器械摘要

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.

常见问题

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.

列明Connexicon Medical , Ltd.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。

K233458CM005 标准 (CM005)；CM004 迷你 (CM004)

官方来源

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