The following data is part of a premarket notification filed by Xiamen Chenyi Plastics Industrial Co. Ltd. with the FDA for Non-prescription Sunglasses.
| Device ID | K935037 |
| 510k Number | K935037 |
| Device Name: | NON-PRESCRIPTION SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | XIAMEN CHENYI PLASTICS INDUSTRIAL CO. LTD. PU NAN, WU CUN Xiamen, Mainland, CN 361004 |
| Contact | Tang-yu Wu |
| Correspondent | Tang-yu Wu XIAMEN CHENYI PLASTICS INDUSTRIAL CO. LTD. PU NAN, WU CUN Xiamen, Mainland, CN 361004 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-18 |
| Decision Date | 1994-04-29 |