The following data is part of a premarket notification filed by Fundamental Industrial Co., Ltd. with the FDA for Fi, Gordy Toy, Welljoy And Others.
| Device ID | K946004 |
| 510k Number | K946004 |
| Device Name: | FI, GORDY TOY, WELLJOY AND OTHERS |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | FUNDAMENTAL INDUSTRIAL CO., LTD. 1/F YIP HING FACTORY BLDG 332 HWUN TONG ROAD Kowloon, Hong Kong, HK |
| Contact | Chow M Tai |
| Correspondent | Chow M Tai FUNDAMENTAL INDUSTRIAL CO., LTD. 1/F YIP HING FACTORY BLDG 332 HWUN TONG ROAD Kowloon, Hong Kong, HK |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-09 |
| Decision Date | 1995-01-31 |