The following data is part of a premarket notification filed by Vision Design Eyewear, Inc. with the FDA for Optical Accessories-spectacle Frames And Sunglasses.
| Device ID | K932125 |
| 510k Number | K932125 |
| Device Name: | OPTICAL ACCESSORIES-SPECTACLE FRAMES AND SUNGLASSES |
| Classification | Frame, Spectacle |
| Applicant | VISION DESIGN EYEWEAR, INC. 13499 BISCAYNE BLVD., SUITE M8 Miami, FL 33181 |
| Contact | Rony Ovadia |
| Correspondent | Rony Ovadia VISION DESIGN EYEWEAR, INC. 13499 BISCAYNE BLVD., SUITE M8 Miami, FL 33181 |
| Product Code | HQZ |
| CFR Regulation Number | 886.5842 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-03 |
| Decision Date | 1993-10-01 |