Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])— 510(k) K251637
Substantially EquivalentDonnevie Medical Technology (Shanghai) Co. , Ltd.
FDA 510(k) clearance K251637 for Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA]), Substantially Equivalent on 2025-08-27. Applicant: Donnevie Medical Technology (Shanghai) Co. , Ltd..
Clearance details
- Applicant
- Donnevie Medical Technology (Shanghai) Co. , Ltd.
- Product code
- Code MQL
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shanghai, CN
Data sourced from openFDA. This site is unofficial and independent of the FDA.