510(k) K030350
K030350 is an FDA 510(k) premarket notification submitted by Optonol, Ltd. for the device "EXPRESS MINI GLAUCOMA SHUNT". The FDA issued a decision of Substantially Equivalent on March 13, 2003. The device falls under product code KYF (Implant, Eye Valve), a Class II device regulated under 21 CFR 886.3920. Optonol, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 13, 2003
- Date Received
- February 3, 2003
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Eye Valve
- Device Class
- Class II
- Regulation Number
- 886.3920
- Review Panel
- OP
- Submission Type