AVAIRA (ENFILCON A) 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 (enfilcon A) Contact Lens.

Pre-market Notification Details

Device IDK113759
510k NumberK113759
Device Name:AVAIRA (ENFILCON A) CONTACT LENS
ClassificationLenses, Soft Contact, Daily Wear
Applicant COOPERVISION, INC. 6150 Stoneridge Mall Road Suite 370 Pleasanton,  CA  94588
ContactKarin Gastineau
CorrespondentKarin Gastineau
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 Received2011-12-21
Decision Date2012-04-03
Summary:summary

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