The following data is part of a premarket notification filed by Seiko Optical Products Of America, Inc. with the FDA for Sunglass, Non-prescription.
| Device ID | K900764 |
| 510k Number | K900764 |
| Device Name: | SUNGLASS, NON-PRESCRIPTION |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | SEIKO OPTICAL PRODUCTS OF AMERICA, INC. 575 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | Robert L Curley |
| Correspondent | Robert L Curley SEIKO OPTICAL PRODUCTS OF AMERICA, INC. 575 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-20 |
| Decision Date | 1990-06-20 |