EPI K Console

Keratome, Ac-powered

Moria SA

The following data is part of a premarket notification filed by Moria Sa with the FDA for Epi K Console.

Pre-market Notification Details

Device IDK172994
510k NumberK172994
Device Name:EPI K Console
ClassificationKeratome, Ac-powered
Applicant Moria SA 15 Rue Georges Besse Antony,  FR
ContactJean-paul Mercereau
CorrespondentCherita James
MSquared Association, Inc 901 King Street, Suite 200 Alexandria,  VA  22314
Product CodeHNO  
CFR Regulation Number886.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-27
Decision Date2017-10-26
Summary:summary

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