ONEUSE- PLUS MICROKERATOME

Keratome, Battery-powered

MORIA S.A.

The following data is part of a premarket notification filed by Moria S.a. with the FDA for Oneuse- Plus Microkeratome.

Pre-market Notification Details

Device IDK040297
510k NumberK040297
Device Name:ONEUSE- PLUS MICROKERATOME
ClassificationKeratome, Battery-powered
Applicant MORIA S.A. 15 RUE GEORGES BESSE Antony,  FR 92160
ContactMelanie Renaud-samiri
CorrespondentMelanie Renaud-samiri
MORIA S.A. 15 RUE GEORGES BESSE Antony,  FR 92160
Product CodeHMY  
CFR Regulation Number886.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-02-09
Decision Date2004-03-31
Summary:summary

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