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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 K082043
Device Name CARRIAZO-PENDULAR MICROKERATOME
Applicant
Schwind Eye-Tech-Solutions GmbH & Co. KG
Mainparkstrasse 6-10
Kleinostheim,  DE 63801
Applicant Contact ROLF SCHWIND
Correspondent
Tuv Sud America, Inc.
1775 Old Highway 8 NW
New Brighton,  MN  55112 -1891
Correspondent Contact STEFAN PREISS
Regulation Number886.4370
Classification Product Code
HNO  
Date Received07/18/2008
Decision Date 08/01/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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