The following data is part of a premarket notification filed by Fashion Italiana, Inc. with the FDA for Fashion Italiana Eyewear.
| Device ID | K933089 |
| 510k Number | K933089 |
| Device Name: | FASHION ITALIANA EYEWEAR |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | FASHION ITALIANA, INC. 8253 NW 56 ST. Miami, FL 33166 |
| Contact | Piero Gallo |
| Correspondent | Piero Gallo FASHION ITALIANA, INC. 8253 NW 56 ST. Miami, FL 33166 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-23 |
| Decision Date | 1993-10-18 |