The following data is part of a premarket notification filed by Simon Marketing, Inc. with the FDA for Sunglasses.
| Device ID | K934837 |
| 510k Number | K934837 |
| Device Name: | SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | SIMON MARKETING, INC. 1575 EYE STREET, N.W. Washington, DC 20005 |
| Contact | Donald R Stone |
| Correspondent | Donald R Stone SIMON MARKETING, INC. 1575 EYE STREET, N.W. Washington, DC 20005 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-05 |
| Decision Date | 1993-12-08 |