The following data is part of a premarket notification filed by Sun World Intl., Inc. with the FDA for Sunglasses.
| Device ID | K974511 |
| 510k Number | K974511 |
| Device Name: | SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | SUN WORLD INTL., INC. 316 ROOSEVELT AVE. Franklin Square, NY 11010 |
| Contact | Lillian Yen |
| Correspondent | Lillian Yen SUN WORLD INTL., INC. 316 ROOSEVELT AVE. Franklin Square, NY 11010 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-01 |
| Decision Date | 1998-01-12 |