FDA 510(k)

CM00622 링크 피부 닫기 시스템 (CM00622 링크)

K-번호: K233460 · 2024-07-15

결정일2024-07-15

제품 코드OMD

자문 위원회SU [원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

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.

자주 묻는 질문

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.

Connexicon Medical , Ltd.를 신청인으로 등재한 기타 기록

K233458CM005 표준 (CM005); CM004 미니 (CM004)

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