The following data is part of a premarket notification filed by Team Chien Industrial Co., Ltd. with the FDA for Sunglasses.
| Device ID | K971412 |
| 510k Number | K971412 |
| Device Name: | SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | TEAM CHIEN INDUSTRIAL CO., LTD. NO. 34-1 HSIN FU TSUN, HSI KANG SHIANG Tainan Hsien, TW |
| Contact | Kuo-tai Kuo |
| Correspondent | Kuo-tai Kuo TEAM CHIEN INDUSTRIAL CO., LTD. NO. 34-1 HSIN FU TSUN, HSI KANG SHIANG Tainan 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 | 1997-04-16 |
| Decision Date | 1997-05-13 |