The following data is part of a premarket notification filed by Klinger Eye Shields, Inc. with the FDA for Sun Filters/shields.
| Device ID | K941829 |
| 510k Number | K941829 |
| Device Name: | SUN FILTERS/SHIELDS |
| Classification | Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) |
| Applicant | KLINGER EYE SHIELDS, INC. 10861 75TH ST. N. Largo, FL 34647 |
| Contact | Laraine Mcalpin |
| Correspondent | Laraine Mcalpin KLINGER EYE SHIELDS, INC. 10861 75TH ST. N. Largo, FL 34647 |
| Product Code | HOY |
| CFR Regulation Number | 886.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-13 |
| Decision Date | 1994-05-17 |