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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 K141954
Device Name XCEL 455 SLIT LAMP
Applicant
Reichert, Inc.
3362 Walden Ave.
Depew,  NY  14043
Applicant Contact THOMAS M HECKMANN
Correspondent
Reichert, Inc.
3362 Walden Ave.
Depew,  NY  14043
Correspondent Contact THOMAS M HECKMANN
Regulation Number886.1850
Classification Product Code
HJO  
Date Received07/18/2014
Decision Date 10/15/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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