510(k) K180895
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 27, 2018
- Date Received
- April 5, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Grid, Amsler
- Device Class
- Class I
- Regulation Number
- 886.1330
- Review Panel
- OP
- Submission Type