510(k) K883822
Clearance Details
- Decision
- SESD (Substantially Equivalent (with conditions))
- Decision Date
- November 22, 1988
- Date Received
- September 7, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pad, Eye
- Device Class
- Class I
- Regulation Number
- 878.4440
- Review Panel
- SU
- Submission Type