The following data is part of a premarket notification filed by Sun Wellen, Inc. with the FDA for Sunglasses.
| Device ID | K942237 |
| 510k Number | K942237 |
| Device Name: | SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | SUN WELLEN, INC. HSING S. RD P.O. BOX 73-38 Taipei, TW |
| Contact | Shelly Lee |
| Correspondent | Shelly Lee SUN WELLEN, INC. HSING S. RD P.O. BOX 73-38 Taipei, TW |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-09 |
| Decision Date | 1994-06-06 |