The following data is part of a premarket notification filed by Taiwan Eva Industrial Co., Inc. with the FDA for Sunglasses (non-prescription Including Photosensitive).
| Device ID | K952438 |
| 510k Number | K952438 |
| Device Name: | SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | TAIWAN EVA INDUSTRIAL CO., INC. P.O. BOX 1445 Kaohsiung, TW |
| Contact | Holly Lin |
| Correspondent | Holly Lin TAIWAN EVA INDUSTRIAL CO., INC. P.O. BOX 1445 Kaohsiung, TW |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-25 |
| Decision Date | 1995-09-12 |