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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 K954058
Device Name BARRAQUER-KRUMEICH REFRACTIVE SET
Applicant
Eyetech M.V.A.
Egerta 53, Postfach 2
Fl-9496 Balzers, Liechtenstein,  DE
Applicant Contact E. KAISER
Correspondent
Eyetech M.V.A.
Egerta 53, Postfach 2
Fl-9496 Balzers, Liechtenstein,  DE
Correspondent Contact E. KAISER
Regulation Number886.4370
Classification Product Code
HNO  
Date Received06/05/1995
Decision Date 11/06/1995
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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