OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION

Accessories, Soft Lens Products

BAUSCH & LOMB, INC.

The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Ocd04 3% Hydrogen Peroxide Cleaning And Disinfecting Soultion.

Pre-market Notification Details

Device IDK112909
510k NumberK112909
Device Name:OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION
ClassificationAccessories, Soft Lens Products
Applicant BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. Rochester,  NY  14609 -3547
ContactTricia Garrett
CorrespondentTricia Garrett
BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. Rochester,  NY  14609 -3547
Product CodeLPN  
CFR Regulation Number886.5928 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-10-03
Decision Date2012-04-30
Summary:summary

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