The following data is part of a premarket notification filed by Leonardo, Inc. with the FDA for Sunglasses.
| Device ID | K940659 |
| 510k Number | K940659 |
| Device Name: | SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | LEONARDO, INC. 115 WEST MADISON Ann Arbor, MI 48103 |
| Contact | Mary K Wolfe |
| Correspondent | Mary K Wolfe LEONARDO, INC. 115 WEST MADISON Ann Arbor, MI 48103 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-15 |
| Decision Date | 1994-06-06 |