METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

Lenses, Soft Contact, Daily Wear

BIOCOMPATIBLES EYEWEAR, INC.

The following data is part of a premarket notification filed by Biocompatibles Eyewear, Inc. with the FDA for Methafilcon A Soft (hydrophilic) Contact Lens For Daily Wear.

Pre-market Notification Details

Device IDK980218
510k NumberK980218
Device Name:METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
ClassificationLenses, Soft Contact, Daily Wear
Applicant BIOCOMPATIBLES EYEWEAR, INC. 1215 BOISSEVAIN AVE. Norfolk,  VA  23507
ContactLisa Hahn
CorrespondentLisa Hahn
BIOCOMPATIBLES EYEWEAR, INC. 1215 BOISSEVAIN AVE. Norfolk,  VA  23507
Product CodeLPL  
CFR Regulation Number886.5925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-01-16
Decision Date1998-03-23
Summary:summary

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