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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cutaneous Tissue Adhesive With Mesh
510(k) Number K233460
Device Name CM00622 LINC Skin Closure System (CM00622 LINC)
Applicant
Connexicon Medical , Ltd.
Synergy Centre
Institute Of Technology Tallaght (Itt)
Dublin,  IE D24 A386
Applicant Contact Martin Brennan
Correspondent
Connexicon Medical , Ltd.
Synergy Centre
Institute Of Technology Tallaght (Itt)
Dublin,  IE D24 A386
Correspondent Contact Martin Brennan
Regulation Number878.4011
Classification Product Code
OMD  
Date Received10/23/2023
Decision Date 07/15/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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