The following data is part of a premarket notification filed by Elegance Optical Manufactory, Ltd. with the FDA for Sunglasses.
| Device ID | K973934 |
| 510k Number | K973934 |
| Device Name: | SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | ELEGANCE OPTICAL MANUFACTORY, LTD. 401 BROADWAY, SUITE 613 New York, NY 10013 |
| Contact | Ester Lai |
| Correspondent | Ester Lai ELEGANCE OPTICAL MANUFACTORY, LTD. 401 BROADWAY, SUITE 613 New York, NY 10013 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-15 |
| Decision Date | 1997-11-18 |