METHAFILCON A

Lenses, Soft Contact, Daily Wear

COOPERVISION, INC.

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

Pre-market Notification Details

Device IDK002625
510k NumberK002625
Device Name:METHAFILCON A
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 Received2000-08-23
Decision Date2000-09-13

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.