FREQUENCY 55, FREQUENCY 55 ASPHERIC, ENCORE, ENCORE TORIC, ONEVIEW, COOPERFLEX

Lenses, Soft Contact, Daily Wear

COOPERVISION, INC.

The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Frequency 55, Frequency 55 Aspheric, Encore, Encore Toric, Oneview, Cooperflex.

Pre-market Notification Details

Device IDK000384
510k NumberK000384
Device Name:FREQUENCY 55, FREQUENCY 55 ASPHERIC, ENCORE, ENCORE TORIC, ONEVIEW, COOPERFLEX
ClassificationLenses, Soft Contact, Daily Wear
Applicant COOPERVISION, INC. 711 NORTH RD. Scottsville,  NY  14546
ContactBonnie Tsymbal
CorrespondentBonnie Tsymbal
COOPERVISION, INC. 711 NORTH RD. Scottsville,  NY  14546
Product CodeLPL  
CFR Regulation Number886.5925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-02-07
Decision Date2000-03-06

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