510(k) K100385
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 24, 2010
- Date Received
- February 16, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Pump, Breast, Powered
- Device Class
- Class II
- Regulation Number
- 884.5160
- Review Panel
- OB
- Submission Type