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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 K082891
FOIA Releasable 510(k) K082891
Device Name LENSTAR, MODEL LS900
Applicant
Haag-Streit AG
1667 Ridgewood Rd.
Wadsworth,  OH  44281
Applicant Contact LENA SATTLER
Correspondent
Haag-Streit AG
1667 Ridgewood Rd.
Wadsworth,  OH  44281
Correspondent Contact LENA SATTLER
Regulation Number886.1850
Classification Product Code
HJO  
Date Received09/30/2008
Decision Date 10/20/2009
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
Recalls CDRH Recalls
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