The following data is part of a premarket notification filed by Wenzhou Winsor Optical International Co., Ltd. with the FDA for Sunglasses & Sport Sunglasses.
| Device ID | K952963 |
| 510k Number | K952963 |
| Device Name: | SUNGLASSES & SPORT SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | WENZHOU WINSOR OPTICAL INTERNATIONAL CO., LTD. NO.1, DISTRICT OF LONGWAN FUPING ECONOMIC DEVEL. ZONE Wenzhou, CN |
| Contact | Chin Ling Kho |
| Correspondent | Chin Ling Kho WENZHOU WINSOR OPTICAL INTERNATIONAL CO., LTD. NO.1, DISTRICT OF LONGWAN FUPING ECONOMIC DEVEL. ZONE Wenzhou, CN |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-26 |
| Decision Date | 1995-09-12 |