Menicon Saline Rinse 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 Saline Rinse Solution.

Pre-market Notification Details

Device IDK151768
510k NumberK151768
Device Name:Menicon Saline Rinse Solution
ClassificationAccessories, Soft Lens Products
Applicant MENICON CO.,LTD. 21-19, AOI 3-CHOME, NAKA-KU Nagoya,  JP 460-0006
ContactTohru Kawaguchi
CorrespondentEllen M Beucler
FORESIGHT REGULATORY STRATEGIES, INC. 187 BALLARDVALE STREET, SUITE 180 Wilmington,  MA  01887
Product CodeLPN  
CFR Regulation Number886.5928 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-06-30
Decision Date2015-08-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00853253003201 K151768 000
00853253003195 K151768 000

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