FDA 510(k) Application Details - K233460

Device Classification Name

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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 D24 A386 IE
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Contact Martin Brennan
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Regulation Number

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Classification Product Code OMD
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Date Received 10/23/2023
Decision Date 07/15/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K233460


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