510(k) clearance
MODO DUO Electric Pump (B11621, B11673)
- 510(k) number
- K261782
- Applicant
- Tomy International, Inc.
- Decision date
- Oct 16, 2026
- Date received
- May 29, 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
- Dyersville, IA, US