The following data is part of a premarket notification filed by Taiwan Eva Industrial Co., Inc. with the FDA for Shield, Eye, Ophthalmic.
| Device ID | K945351 |
| 510k Number | K945351 |
| Device Name: | SHIELD, EYE, OPHTHALMIC |
| Classification | Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) |
| 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 | HOY |
| CFR Regulation Number | 886.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-14 |
| Decision Date | 1994-12-13 |