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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Keratome, Ac-Powered
510(k) Number K032836
Device Name M3 MICROKERATOME
Applicant
Moria SA
15 Rue Georges Besse
Antony,  FR 92160
Applicant Contact MELANIE RENAUD-SAMIRI
Correspondent
Moria SA
15 Rue Georges Besse
Antony,  FR 92160
Correspondent Contact MELANIE RENAUD-SAMIRI
Regulation Number886.4370
Classification Product Code
HNO  
Date Received09/11/2003
Decision Date 06/18/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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