The following data is part of a premarket notification filed by Kingsun Optical Ent. Co., Ltd. with the FDA for Non-prescription Sunglasses.
| Device ID | K941055 |
| 510k Number | K941055 |
| Device Name: | NON-PRESCRIPTION SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | KINGSUN OPTICAL ENT. CO., LTD. CHUNG-CHENG ROAD, CHIA VILLAGE JEN-TEH HSIANG, TAIWAN HSIEN. Taiwan, R.o.c., TW |
| Contact | Susie Chen |
| Correspondent | Susie Chen KINGSUN OPTICAL ENT. CO., LTD. CHUNG-CHENG ROAD, CHIA VILLAGE JEN-TEH HSIANG, TAIWAN HSIEN. Taiwan, R.o.c., TW |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-03 |
| Decision Date | 1994-04-12 |