The following data is part of a premarket notification filed by Taipan Optical Company Ltd. with the FDA for Non-prescription Sunglasses.
| Device ID | K974179 |
| 510k Number | K974179 |
| Device Name: | NON-PRESCRIPTION SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | TAIPAN OPTICAL COMPANY LTD. 18 TAK FUNG ST., SUITE 1702 ONE HARBOURFRONT 17TH FL. Kowloon, HK |
| Contact | Henry Hsu |
| Correspondent | Henry Hsu TAIPAN OPTICAL COMPANY LTD. 18 TAK FUNG ST., SUITE 1702 ONE HARBOURFRONT 17TH FL. Kowloon, HK |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-06 |
| Decision Date | 1997-12-01 |