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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 K061330
Device Name PSL PORTABLE SLIT LAMP
Applicant
REICHERT, INC.
3374 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
Regulation Number886.1850
Classification Product Code
HJO  
Date Received05/12/2006
Decision Date 05/25/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
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