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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 K063750
Device Name XCEL 255 SLIT LAMP
Applicant
REICHERT INC.
3362 WALDEN AVE.
DEPEW,  NY  14043
Applicant Contact SANDRA BROWN
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact NEIL E DEVINE, JR.
Regulation Number886.1850
Classification Product Code
HJO  
Date Received12/19/2006
Decision Date 12/20/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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