510(k) K180863
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 2018
- Date Received
- April 2, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Portable, Aspiration (Manual Or Powered)
- Device Class
- Class II
- Regulation Number
- 878.4780
- Review Panel
- SU
- Submission Type