The following data is part of a premarket notification filed by Kt Optique, Inc. with the FDA for Spectacle Frames.
| Device ID | K943792 |
| 510k Number | K943792 |
| Device Name: | SPECTACLE FRAMES |
| Classification | Frame, Spectacle |
| Applicant | KT OPTIQUE, INC. 5-627 ITAGAKI Fukui, 910, JP |
| Contact | Ken Iida |
| Correspondent | Ken Iida KT OPTIQUE, INC. 5-627 ITAGAKI Fukui, 910, JP |
| Product Code | HQZ |
| CFR Regulation Number | 886.5842 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-03 |
| Decision Date | 1994-09-14 |