K233458
- 510(k) number
- K233458
- Device name
- CM005 Standard (CM005); CM004 Mini (CM004)
- Applicant
- Connexicon Medical , Ltd. IE
- Product code
- MPN — Tissue Adhesive For The Topical Approximation Of Ski
- Decision date
- 2024-07-15
- Date received
- 2023-10-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K233458.pdf
Official FDA record: K233458
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.