The following data is part of a premarket notification filed by Oakley, Inc. with the FDA for Oakley, Inc Sunglasses.
| Device ID | K961268 |
| 510k Number | K961268 |
| Device Name: | OAKLEY, INC SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | OAKLEY, INC. 10 HOLLAND Irvine, CA 92718 |
| Contact | Link Newcomb |
| Correspondent | Link Newcomb OAKLEY, INC. 10 HOLLAND Irvine, CA 92718 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-02 |
| Decision Date | 1996-04-24 |