510(k) K905129
K905129 is an FDA 510(k) premarket notification submitted by Wright Medical Corp. for the device "BAERVELDT GLAUCOMA IMPLANT". The FDA issued a decision of Substantially Equivalent on February 11, 1991. The device falls under product code KYF (Implant, Eye Valve), a Class II device regulated under 21 CFR 886.3920. Wright Medical Corp. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 11, 1991
- Date Received
- November 14, 1990
- Clearance Type
- Traditional
- 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