PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR

Lenses, Soft Contact, Daily Wear

COOPERVISION, INC.

The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Proclear Multifocal Toric And Xr And Toric Xr.

Pre-market Notification Details

Device IDK081865
510k NumberK081865
Device Name:PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR
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 Received2008-07-01
Decision Date2008-09-29
Summary:summary

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