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 |