TETRAFILCON A HYDROPHILIC CONTACT LENSES

Lenses, Soft Contact, Daily Wear

COOPERVISION, INC.

The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Tetrafilcon A Hydrophilic Contact Lenses.

Pre-market Notification Details

Device IDK950968
510k NumberK950968
Device Name:TETRAFILCON A HYDROPHILIC CONTACT LENSES
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-03-01
Decision Date1995-07-25

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