The following data is part of a premarket notification filed by Sun Glory Optic Co Ltd. with the FDA for Sunglasses.
| Device ID | K944281 |
| 510k Number | K944281 |
| Device Name: | SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | SUN GLORY OPTIC CO LTD. 4F, NO. 97, FU-YANG ST. P.O. BOX 26-484 Taipei, TW |
| Contact | C S Chen |
| Correspondent | C S Chen SUN GLORY OPTIC CO LTD. 4F, NO. 97, FU-YANG ST. P.O. BOX 26-484 Taipei, TW |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-02 |
| Decision Date | 1994-10-03 |