The following data is part of a premarket notification filed by Sungold Eyewear, Inc. with the FDA for Arctic Premier Series.
| Device ID | K944700 |
| 510k Number | K944700 |
| Device Name: | ARCTIC PREMIER SERIES |
| Classification | Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) |
| Applicant | SUNGOLD EYEWEAR, INC. 5866 S. 194TH ST. Kent, WA 98032 |
| Contact | Michael B Johnson |
| Correspondent | Michael B Johnson SUNGOLD EYEWEAR, INC. 5866 S. 194TH ST. Kent, WA 98032 |
| Product Code | HOY |
| CFR Regulation Number | 886.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-23 |
| Decision Date | 1994-12-22 |