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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 K172994
Device Name EPI K Console
Applicant
Moria SA
15 Rue Georges Besse
Antony,  FR
Applicant Contact Jean-Paul Mercereau
Correspondent
Msquared Association, Inc.
901 King St., Suite 200
Alexandria,  VA  22314
Correspondent Contact Cherita James
Regulation Number886.4370
Classification Product Code
HNO  
Date Received09/27/2017
Decision Date 10/26/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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