The following data is part of a premarket notification filed by Promedex, Inc. with the FDA for Promoglass(tm) Sunglasses (non-prescription).
| Device ID | K914407 |
| 510k Number | K914407 |
| Device Name: | PROMOGLASS(TM) SUNGLASSES (NON-PRESCRIPTION) |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | PROMEDEX, INC. C/O RICHARD HAMER ASSOC., INC. P.O. BOX 16598 Ft. Worth, TX 76162 |
| Contact | Richard A Hamer |
| Correspondent | Richard A Hamer PROMEDEX, INC. C/O RICHARD HAMER ASSOC., INC. P.O. BOX 16598 Ft. Worth, TX 76162 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-02 |
| Decision Date | 1991-12-31 |