Menicon 3% Hydrogen Peroxide Cleaning And Disinfecting Solution

Accessories, Soft Lens Products

Menicon Co., Ltd.

The following data is part of a premarket notification filed by Menicon Co., Ltd. with the FDA for Menicon 3% Hydrogen Peroxide Cleaning And Disinfecting Solution.

Pre-market Notification Details

Device IDK191872
510k NumberK191872
Device Name:Menicon 3% Hydrogen Peroxide Cleaning And Disinfecting Solution
ClassificationAccessories, Soft Lens Products
Applicant Menicon Co., Ltd. 21-19, Aoi 3, Naka-ku Nagoya,  JP 460-0006
ContactTetsuji Kawai
CorrespondentHaosheng Li
Foresight Regulatory Strategies, Inc. 3-21-19, Aoi, Naka-ku 460-0006 Nagoya,  JP
Product CodeLPN  
CFR Regulation Number886.5928 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOphthalmic
510k Review PanelOphthalmic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-12
Decision Date2020-03-02

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