EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION

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 Ezs05 Cleaning And Disinfecting Solution, Bausch + Lomb Ezs05 Cleaning And Disinfecting Solution.

Pre-market Notification Details

Device IDK111877
510k NumberK111877
Device Name:EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION
ClassificationAccessories, Soft Lens Products
Applicant BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. Rochester,  NY  14609 -3547
ContactHeather Michaels
CorrespondentHeather Michaels
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 Received2011-07-01
Decision Date2012-01-24
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.