CLERZ LUBRICATING & REWETTING EYE DROPS

Lens, Contact (polymethylmethacrylate)

COOPERVISION, INC.

The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Clerz Lubricating & Rewetting Eye Drops.

Pre-market Notification Details

Device IDK830740
510k NumberK830740
Device Name:CLERZ LUBRICATING & REWETTING EYE DROPS
ClassificationLens, Contact (polymethylmethacrylate)
Applicant COOPERVISION, INC. PERMALENS HOUSE 1 BOTLEY ROAD, HEDGE END Southampton,  GB S033hb
Product CodeHPX  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-03-08
Decision Date1983-06-02

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