The following data is part of a premarket notification filed by Cutler & Gross Sloan Optical Ltd. with the FDA for Sunglasses.
| Device ID | K910329 |
| 510k Number | K910329 |
| Device Name: | SUNGLASSES |
| Classification | Spectacle, Magnifying |
| Applicant | CUTLER & GROSS SLOAN OPTICAL LTD. 16 KNIGHTSBRIDGE GREEN LONDON SW1X 7QL England, GB |
| Contact | Graham Cutler |
| Correspondent | Graham Cutler CUTLER & GROSS SLOAN OPTICAL LTD. 16 KNIGHTSBRIDGE GREEN LONDON SW1X 7QL England, GB |
| Product Code | HOI |
| CFR Regulation Number | 886.5840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-25 |
| Decision Date | 1991-03-12 |