The following data is part of a premarket notification filed by Esparkle International Co., Ltd. with the FDA for Sunglasses.
| Device ID | K935734 |
| 510k Number | K935734 |
| Device Name: | SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | ESPARKLE INTERNATIONAL CO., LTD. NO. 344, 3F-1, FUHSING NORTH ROAD Taipei, Taiwan, TW |
| Contact | Melody Chou |
| Correspondent | Melody Chou ESPARKLE INTERNATIONAL CO., LTD. NO. 344, 3F-1, FUHSING NORTH ROAD Taipei, Taiwan, TW |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-01 |
| Decision Date | 1994-04-06 |