510(k) K943963
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 14, 1994
- Date Received
- August 15, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sunglasses (Non-Prescription Including Photosensitive)
- Device Class
- Class I
- Regulation Number
- 886.5850
- Review Panel
- OP
- Submission Type