The following data is part of a premarket notification filed by Jane Fui Optical Co., Ltd. with the FDA for Frames (spectacles).
| Device ID | K914239 |
| 510k Number | K914239 |
| Device Name: | FRAMES (SPECTACLES) |
| Classification | Frame, Spectacle |
| Applicant | JANE FUI OPTICAL CO., LTD. READING GLASSES TO GO 9121 KING ARTHUR DRIVE Dallas, TX 75247 |
| Contact | Robert Granoff |
| Correspondent | Robert Granoff JANE FUI OPTICAL CO., LTD. READING GLASSES TO GO 9121 KING ARTHUR DRIVE Dallas, TX 75247 |
| Product Code | HQZ |
| CFR Regulation Number | 886.5842 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-18 |
| Decision Date | 1991-12-16 |