510(k) K972089
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 3, 1997
- Date Received
- June 4, 1997
- 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