AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS

Lenses, Soft Contact, Daily Wear

COOPERVISION, INC.

The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Avaira Spheric And Toric (enfilcon A) Soft Contact Lens.

Pre-market Notification Details

Device IDK133627
510k NumberK133627
Device Name:AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS
ClassificationLenses, Soft Contact, Daily Wear
Applicant COOPERVISION, INC. 6150 Stoneridge Mall Road Suite 370 Pleasanton,  CA  94588
ContactAnnette Nelson
CorrespondentAnnette Nelson
COOPERVISION, INC. 6150 Stoneridge Mall Road Suite 370 Pleasanton,  CA  94588
Product CodeLPL  
CFR Regulation Number886.5925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-11-26
Decision Date2013-12-23
Summary:summary

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