FDA.reportPublic FDA data

510(k) K233458

Device
CM005 Standard (CM005); CM004 Mini (CM004)
Applicant
Connexicon Medical , Ltd.
510(k) number
K233458
Product code
MPN
Decision
Substantially Equivalent (SESE)
Decision date
2024-07-15
Date received
2023-10-23
Regulation
878.4010
Classification name
Tissue Adhesive For The Topical Approximation Of Skin
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Martin Brennan
Address
Synergy Centre Institute Of Technology Tallaght (Itt) Dublin IE D24 A386 D24 A386

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K141157BONDEASE TOPICAL SKIN ADHESIVEOptmed, Inc.2015-12-22
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