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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biomicroscope, Slit-Lamp, Ac-Powered
510(k) Number K100202
Device Name SLIT LAMP BO 900, BQ 900, BP900
Applicant
Haag-Streit AG
Gartenstadtstrasse 10
Koeniz,  CH CH-3098
Applicant Contact OSCAR BANZ
Correspondent
Tuv Sud America, Inc.
1775 Old Hwy. 8 NW
New Brighton,  MN  55112
Regulation Number886.1850
Classification Product Code
HJO  
Date Received01/25/2010
Decision Date 03/19/2010
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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