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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 K041206
Device Name EPITOME SYSTEM
Applicant
Gebauer Medizintechnik GmbH
54 Forest St.
Lexington,  MA  02421
Applicant Contact KIMBERLEY DONEY
Correspondent
Gebauer Medizintechnik GmbH
54 Forest St.
Lexington,  MA  02421
Correspondent Contact KIMBERLEY DONEY
Regulation Number886.4370
Classification Product Code
HNO  
Date Received05/07/2004
Decision Date 09/15/2004
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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