The following data is part of a premarket notification filed by Optique Marquis, Div. Sugerose, Inc. with the FDA for (eyeglass) Frames And Sunglasses.
| Device ID | K901167 |
| 510k Number | K901167 |
| Device Name: | (EYEGLASS) FRAMES AND SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | OPTIQUE MARQUIS, DIV. SUGEROSE, INC. P.O. BOX 2078 San Antonio, TX 78297 |
| Contact | Charles I Solomon |
| Correspondent | Charles I Solomon OPTIQUE MARQUIS, DIV. SUGEROSE, INC. P.O. BOX 2078 San Antonio, TX 78297 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-13 |
| Decision Date | 1990-06-14 |