510(k) K963434
K963434 is an FDA 510(k) premarket notification submitted by Escalon Trek Medical for the device "VISCOUS FLUID SYSTEM". The FDA issued a decision of Substantially Equivalent on November 25, 1996. The device falls under product code MRH (Pump, Infusion, Ophthalmic), a Class II device regulated under 21 CFR 880.5725. Escalon Trek Medical has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 25, 1996
- Date Received
- August 30, 1996
- 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