510(k) clearance
Cimilre Dual Max
- 510(k) number
- K260643
- Applicant
- Cimilre Co., Ltd.
- Decision date
- Aug 21, 2026
- Date received
- Feb 27, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- HGX
- Device type
- Pump, Breast, Powered
- Device class
- Class II
- Regulation
- 21 CFR 884.5160
- Advisory committee
- Obstetrics/Gynecology
- Statement or summary
- Summary
- Third party
- N
- Location
- Cheonan-Si, Chungcheongnam-Do,, KR