510(k) K895772
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 16, 1990
- Date Received
- September 26, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Attachment, Eyepiece, For Insertion Of Prescription Lens
- Device Class
- Class I
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type