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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
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