The following data is part of a premarket notification filed by Wenzhou Hindar Optical Co., Ltd. with the FDA for Non-prescription Sunglasses.
| Device ID | K974861 |
| 510k Number | K974861 |
| Device Name: | NON-PRESCRIPTION SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | WENZHOU HINDAR OPTICAL CO., LTD. NO. 46-5 LIMING MID RD. Wenzhou City, CN |
| Contact | Zhou S Kao |
| Correspondent | Zhou S Kao WENZHOU HINDAR OPTICAL CO., LTD. NO. 46-5 LIMING MID RD. Wenzhou City, CN |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-29 |
| Decision Date | 1998-01-27 |