510(k) K241705
MilkMate Breast Pump (A0006); MilkMate Kit (sterile, single-use only), 21 mm breast shield (A0005-21); MilkMate Kit (sterile, single-use only), 24 mm breast shield (A0005-24) by
Milkmate Products, Inc.
— Product Code HGX
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 12, 2024
- Date Received
- June 13, 2024
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Breast, Powered
- Device Class
- Class II
- Regulation Number
- 884.5160
- Review Panel
- OB
- Submission Type