The following data is part of a premarket notification filed by Marchon Eyewear, Inc. with the FDA for Marchon/marcolin Sunglasses.
| Device ID | K933734 |
| 510k Number | K933734 |
| Device Name: | MARCHON/MARCOLIN SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | MARCHON EYEWEAR, INC. 35 HUB DR. Melville, NY 11747 |
| Contact | Joseph P Sherer |
| Correspondent | Joseph P Sherer MARCHON EYEWEAR, INC. 35 HUB DR. Melville, NY 11747 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-02 |
| Decision Date | 1993-09-20 |