The following data is part of a premarket notification filed by Tong Yang Optical Co. with the FDA for Sunglasses.
| Device ID | K973490 |
| 510k Number | K973490 |
| Device Name: | SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | TONG YANG OPTICAL CO. C.P.O. BOX 193 Daegu, KR 700-600 |
| Contact | Jae Yul Park |
| Correspondent | Jae Yul Park TONG YANG OPTICAL CO. C.P.O. BOX 193 Daegu, KR 700-600 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-15 |
| Decision Date | 1997-09-30 |