510(k) K912269
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 7, 1991
- Date Received
- May 22, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ring, Ophthalmic (Flieringa)
- Device Class
- Class I
- Regulation Number
- 886.4350
- Review Panel
- OP
- Submission Type