The following data is part of a premarket notification filed by Sun Island Enterprise Co., Ltd. with the FDA for Sunglasses.
| Device ID | K944398 |
| 510k Number | K944398 |
| Device Name: | SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | SUN ISLAND ENTERPRISE CO., LTD. NO. 109, MING CHUNG ROAD Hsin Tien City Taipei Hsien, TW |
| Contact | Sandy Chen |
| Correspondent | Sandy Chen SUN ISLAND ENTERPRISE CO., LTD. NO. 109, MING CHUNG ROAD Hsin Tien City Taipei Hsien, TW |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-09 |
| Decision Date | 1994-12-15 |