The following data is part of a premarket notification filed by Sunshine Opticians, Inc. with the FDA for Sunglasses.
| Device ID | K925539 |
| 510k Number | K925539 |
| Device Name: | SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | SUNSHINE OPTICIANS, INC. P.O. BOX 765 Tainan, Taiwan R.o.c., CN |
| Contact | Shieh |
| Correspondent | Shieh SUNSHINE OPTICIANS, INC. P.O. BOX 765 Tainan, Taiwan R.o.c., CN |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-02 |
| Decision Date | 1993-12-08 |