SUNGLASSES

Spectacle, Magnifying

CUTLER & GROSS SLOAN OPTICAL LTD.

The following data is part of a premarket notification filed by Cutler & Gross Sloan Optical Ltd. with the FDA for Sunglasses.

Pre-market Notification Details

Device IDK910329
510k NumberK910329
Device Name:SUNGLASSES
ClassificationSpectacle, Magnifying
Applicant CUTLER & GROSS SLOAN OPTICAL LTD. 16 KNIGHTSBRIDGE GREEN LONDON SW1X 7QL England,  GB
ContactGraham Cutler
CorrespondentGraham Cutler
CUTLER & GROSS SLOAN OPTICAL LTD. 16 KNIGHTSBRIDGE GREEN LONDON SW1X 7QL England,  GB
Product CodeHOI  
CFR Regulation Number886.5840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-01-25
Decision Date1991-03-12

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.