The following data is part of a premarket notification filed by Sunny Union Industrial Co., Ltd. with the FDA for Spectacle Frames.
| Device ID | K943442 |
| 510k Number | K943442 |
| Device Name: | SPECTACLE FRAMES |
| Classification | Frame, Spectacle |
| Applicant | SUNNY UNION INDUSTRIAL CO., LTD. P.O. BOX 53-1105, 4F, NO. 39 LANE 131 YEN - CHI STREET Taipei, TW |
| Contact | Teddy Wang |
| Correspondent | Teddy Wang SUNNY UNION INDUSTRIAL CO., LTD. P.O. BOX 53-1105, 4F, NO. 39 LANE 131 YEN - CHI STREET Taipei, TW |
| Product Code | HQZ |
| CFR Regulation Number | 886.5842 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-18 |
| Decision Date | 1994-08-02 |