510(k) K853359
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 24, 1985
- Date Received
- August 12, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Table, Instrument, Powered, Ophthalmic
- Device Class
- Class I
- Regulation Number
- 886.4855
- Review Panel
- OP
- Submission Type