510(k) K991072
K991072 is an FDA 510(k) premarket notification submitted by New World Medical, Inc. for the device "AHMED GLAUCOMA VALVE IMPLANT". The FDA issued a decision of Substantially Equivalent on July 13, 1999. The device falls under product code KYF (Implant, Eye Valve), a Class II device regulated under 21 CFR 886.3920. New World Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 13, 1999
- Date Received
- March 31, 1999
- 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