LEO COLORS, LEO ASPHERIC COLORS, LEO TORIC COLORS

Lenses, Soft Contact, Daily Wear

COOPERVISION, INC.

The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Leo Colors, Leo Aspheric Colors, Leo Toric Colors.

Pre-market Notification Details

Device IDK041138
510k NumberK041138
Device Name:LEO COLORS, LEO ASPHERIC COLORS, LEO TORIC COLORS
ClassificationLenses, Soft Contact, Daily Wear
Applicant COOPERVISION, INC. 711 NORTH RD. Scottsville,  NY  14546
ContactBonnie J Tsymbal
CorrespondentBonnie J Tsymbal
COOPERVISION, INC. 711 NORTH RD. Scottsville,  NY  14546
Product CodeLPL  
CFR Regulation Number886.5925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-04-30
Decision Date2004-07-23
Summary:summary

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