CARRIAZO BARRAQUER SINGLE USE MICROKERATOME

Keratome, Battery-powered

MORIA, INC.

The following data is part of a premarket notification filed by Moria, Inc. with the FDA for Carriazo Barraquer Single Use Microkeratome.

Pre-market Notification Details

Device IDK003594
510k NumberK003594
Device Name:CARRIAZO BARRAQUER SINGLE USE MICROKERATOME
ClassificationKeratome, Battery-powered
Applicant MORIA, INC. 15 RUE GEORGES BESSE Antony,  FR 92160
ContactDavid Conrad
CorrespondentDavid Conrad
MORIA, INC. 15 RUE GEORGES BESSE Antony,  FR 92160
Product CodeHMY  
CFR Regulation Number886.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-11-21
Decision Date2001-03-09

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