510(k) K891584
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 8, 1989
- Date Received
- March 20, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
- Device Class
- Class I
- Regulation Number
- 878.4700
- Review Panel
- SU
- Submission Type