The following data is part of a premarket notification filed by American Hospital Supply Corp. with the FDA for Fox Eye Shields.
| Device ID | K810098 |
| 510k Number | K810098 |
| Device Name: | FOX EYE SHIELDS |
| Classification | Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) |
| Applicant | AMERICAN HOSPITAL SUPPLY CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HOY |
| CFR Regulation Number | 886.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-01-19 |
| Decision Date | 1981-02-27 |