The following data is part of a premarket notification filed by Nouveau Eyewear with the FDA for Sunglasses W/non Prescript Lenses W/photo Sensitiv.
| Device ID | K903739 |
| 510k Number | K903739 |
| Device Name: | SUNGLASSES W/NON PRESCRIPT LENSES W/PHOTO SENSITIV |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | NOUVEAU EYEWEAR 17802 DAVENPORT #102 Dallas, TX 75252 |
| Contact | Nancy Molny |
| Correspondent | Nancy Molny NOUVEAU EYEWEAR 17802 DAVENPORT #102 Dallas, TX 75252 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-16 |
| Decision Date | 1990-09-17 |