The following data is part of a premarket notification filed by Colors In Optics Ltd. with the FDA for Color Optic Corneal Eye Shield.
| Device ID | K843961 |
| 510k Number | K843961 |
| Device Name: | COLOR OPTIC CORNEAL EYE SHIELD |
| Classification | Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) |
| Applicant | COLORS IN OPTICS LTD. 18 STONELEIGH CLOSE Scarsdale, NY 10583 |
| Contact | Andrew P Brucker |
| Correspondent | Andrew P Brucker COLORS IN OPTICS LTD. 18 STONELEIGH CLOSE Scarsdale, NY 10583 |
| Product Code | HOY |
| CFR Regulation Number | 886.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-11 |
| Decision Date | 1984-11-28 |