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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Keratome, Battery-Powered
510(k) Number K002191
Device Name CARRIAZO BARRAQUER II MICROKERATOME
Applicant
Moria, Inc.
15 Rue Georges Besse
Antony,  FR 92160
Applicant Contact DAVID CONRAD
Correspondent
Moria, Inc.
15 Rue Georges Besse
Antony,  FR 92160
Correspondent Contact DAVID CONRAD
Regulation Number886.4370
Classification Product Code
HMY  
Date Received07/20/2000
Decision Date 10/12/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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