BENZETHONIUM CHLORIDE

Lens, Contact (polymethylmethacrylate)

BLAIREX LABORATORIES, INC.

The following data is part of a premarket notification filed by Blairex Laboratories, Inc. with the FDA for Benzethonium Chloride.

Pre-market Notification Details

Device IDK833903
510k NumberK833903
Device Name:BENZETHONIUM CHLORIDE
ClassificationLens, Contact (polymethylmethacrylate)
Applicant BLAIREX LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeHPX  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-11-14
Decision Date1984-05-30

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