PROCLEAR COMPATIBLES DAILY WEAR CONTACT LENS

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 Proclear Compatibles Daily Wear Contact Lens.

Pre-market Notification Details

Device IDK970095
510k NumberK970095
Device Name:PROCLEAR COMPATIBLES DAILY WEAR CONTACT LENS
ClassificationLenses, Soft Contact, Daily Wear
Applicant BIOCOMPATIBLES EYEWEAR, INC. 1215 BOISSEVAIN AVE. Norfolk,  VA  23507
ContactShirley Mcgarvey
CorrespondentShirley Mcgarvey
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 Received1997-01-10
Decision Date1997-04-03

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