The following data is part of a premarket notification filed by Sunrise International Business with the FDA for New Eyes Eyeglass Frame.
| Device ID | K940250 |
| 510k Number | K940250 |
| Device Name: | NEW EYES EYEGLASS FRAME |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | SUNRISE INTERNATIONAL BUSINESS 617 MANOMET COURT Schaumburg, IL 60173 |
| Contact | David H Xu, Ph,d. |
| Correspondent | David H Xu, Ph,d. SUNRISE INTERNATIONAL BUSINESS 617 MANOMET COURT Schaumburg, IL 60173 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-21 |
| Decision Date | 1994-04-19 |