510(k) K052219
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 13, 2005
- Date Received
- August 15, 2005
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type