510(k) K844895
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 24, 1985
- Date Received
- December 17, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fluid, Intraocular
- Device Class
- Class III
- Regulation Number
- 886.4275
- Review Panel
- OP
- Submission Type