The following data is part of a premarket notification filed by Wenzhou Yian Optical International, Co., Ltd. with the FDA for Sunglasses.
| Device ID | K953947 |
| 510k Number | K953947 |
| Device Name: | SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | WENZHOU YIAN OPTICAL INTERNATIONAL, CO., LTD. 3308 INDUSTRY DR. Signal Hill, CA 90806 |
| Contact | James K Dillon |
| Correspondent | James K Dillon WENZHOU YIAN OPTICAL INTERNATIONAL, CO., LTD. 3308 INDUSTRY DR. Signal Hill, CA 90806 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-16 |
| Decision Date | 1995-09-12 |