The following data is part of a premarket notification filed by Sun-set Enterprise Co. Ltd. with the FDA for Non-prescription Sunglasses.
| Device ID | K941441 |
| 510k Number | K941441 |
| Device Name: | NON-PRESCRIPTION SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | SUN-SET ENTERPRISE CO. LTD. 2 FL. NO. 39 LANE 128 CHING HWA ST. Taipei China, TW |
| Contact | Steven Liang |
| Correspondent | Steven Liang SUN-SET ENTERPRISE CO. LTD. 2 FL. NO. 39 LANE 128 CHING HWA ST. Taipei China, TW |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-24 |
| Decision Date | 1994-07-12 |