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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 K131589
Device Name KEELER SLIT LAMP H-SERIES
Applicant
Keeler, Ltd.
Clewer Hill Rd.
Windsor, Berkshire,  GB SL4 4AA
Applicant Contact NICKIE POWER
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  NC  27709
Correspondent Contact JEFF D RONGERO
Regulation Number886.1850
Classification Product Code
HJO  
Date Received05/31/2013
Decision Date 06/27/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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