510(k) K905703
K905703 is an FDA 510(k) premarket notification submitted by Hood Laboratories for the device "KRUPIN EYE VALVE WITH DISK". The FDA issued a decision of Substantially Equivalent on March 15, 1991. The device falls under product code KYF (Implant, Eye Valve), a Class II device regulated under 21 CFR 886.3920. Hood Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 15, 1991
- Date Received
- December 20, 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