MENICON PROGENT REMOVER

Products, Contact Lens Care, Rigid Gas Permeable

MENICON CO. LTD.

The following data is part of a premarket notification filed by Menicon Co. Ltd. with the FDA for Menicon Progent Remover.

Pre-market Notification Details

Device IDK002140
510k NumberK002140
Device Name:MENICON PROGENT REMOVER
ClassificationProducts, Contact Lens Care, Rigid Gas Permeable
Applicant MENICON CO. LTD. 269A BALLARDVALE ST. Wilmington,  MA  01887
ContactBeverley D Venuti
CorrespondentBeverley D Venuti
MENICON CO. LTD. 269A BALLARDVALE ST. Wilmington,  MA  01887
Product CodeMRC  
CFR Regulation Number886.5918 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-07-17
Decision Date2000-10-10

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