510(k) K974253
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 25, 1998
- Date Received
- November 13, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion, Ophthalmic
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- OP
- Submission Type