The following data is part of a premarket notification filed by Three Leaves Industrial Co., Ltd. with the FDA for Sunglasses.
| Device ID | K941296 |
| 510k Number | K941296 |
| Device Name: | SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | THREE LEAVES INDUSTRIAL CO., LTD. P.O. BOX 36-827 Taipei, Taiwan, R.o.c., CN |
| Contact | Jack White |
| Correspondent | Jack White THREE LEAVES INDUSTRIAL CO., LTD. P.O. BOX 36-827 Taipei, Taiwan, R.o.c., CN |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-17 |
| Decision Date | 1994-06-03 |