DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPI

Lenses, Soft Contact, Daily Wear

WESLEY JESSEN CORP.

The following data is part of a premarket notification filed by Wesley Jessen Corp. with the FDA for Durasoft 3 Uv (phemfilcon A) Optifit Toric (hydrophilic) Contact Lenses, Durasoft 3 Uv (phemfilcon A) Spherical (hydropi.

Pre-market Notification Details

Device IDK993935
510k NumberK993935
Device Name:DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPI
ClassificationLenses, Soft Contact, Daily Wear
Applicant WESLEY JESSEN CORP. 333 EAST HOWARD AVE. Des Plaines,  IL  60018
ContactJoseph F Foos
CorrespondentJoseph F Foos
WESLEY JESSEN CORP. 333 EAST HOWARD AVE. Des Plaines,  IL  60018
Product CodeLPL  
CFR Regulation Number886.5925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-11-19
Decision Date1999-12-21
Summary:summary

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