510(k) K980822
K980822 is an FDA 510(k) premarket notification submitted by Fci Ophthalmics, Inc. for the device "TITANIUM PEG SYSTEM". The FDA issued a decision of Substantially Equivalent on July 9, 1998. The device falls under product code MQU (Ocular Peg), a Class II device regulated under 21 CFR 886.3320. Fci Ophthalmics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 9, 1998
- Date Received
- March 3, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ocular Peg
- Device Class
- Class II
- Regulation Number
- 886.3320
- Review Panel
- OP
- Submission Type