510(k) K012266
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 12, 2001
- Date Received
- July 18, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Pump, Infusion
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type