The following data is part of a premarket notification filed by Hwa Meei Optical Co., Ltd. with the FDA for Sunglasses (non-prescription).
| Device ID | K940778 |
| 510k Number | K940778 |
| Device Name: | SUNGLASSES (NON-PRESCRIPTION) |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | HWA MEEI OPTICAL CO., LTD. 28-2, SHA-LUEN CHUNG SHA VILLAGE Tainan, China (taiwan) 745, TW 745 |
| Contact | Cheng Hau Chen |
| Correspondent | Cheng Hau Chen HWA MEEI OPTICAL CO., LTD. 28-2, SHA-LUEN CHUNG SHA VILLAGE Tainan, China (taiwan) 745, TW 745 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-22 |
| Decision Date | 1994-04-06 |