510(k) K941829
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 17, 1994
- Date Received
- April 13, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- Device Class
- Class I
- Regulation Number
- 886.4750
- Review Panel
- OP
- Submission Type