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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tissue Adhesive For The Topical Approximation Of Skin
510(k) Number K233458
Device Name CM005 Standard (CM005); CM004 Mini (CM004)
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 Number878.4010
Classification Product Code
MPN  
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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