K260643
- 510(k) number
- K260643
- Device name
- Cimilre Dual Max
- Applicant
- Cimilre Co., Ltd. KR
- Product code
- HGX — Pump, Breast, Powered
- Decision date
- 2026-08-21
- Date received
- 2026-02-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K260643.pdf
Official FDA record: K260643
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.