The following data is part of a premarket notification filed by H. Girard S.a. with the FDA for Girard Sunglasses (non-prescription).
| Device ID | K861759 |
| 510k Number | K861759 |
| Device Name: | GIRARD SUNGLASSES (NON-PRESCRIPTION) |
| Classification | Lens, Spectacle, Non-custom (prescription) |
| Applicant | H. GIRARD S.A. 39300 CHAMPAGNOLE France, FR |
| Contact | J. Y Gallet |
| Correspondent | J. Y Gallet H. GIRARD S.A. 39300 CHAMPAGNOLE France, FR |
| Product Code | HQG |
| CFR Regulation Number | 886.5844 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-06 |
| Decision Date | 1986-06-09 |