510(k) K925606
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 29, 1994
- Date Received
- November 5, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Marker, Ocular
- Device Class
- Class I
- Regulation Number
- 886.4570
- Review Panel
- OP
- Submission Type