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FDA 510(k) Application Details - K233460
Device Classification Name
More FDA Info for this Device
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
Other 510(k) Applications for this Company
Contact
Martin Brennan
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OMD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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