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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 K924782
Device Name BURTON SLIT LAMP - MODEL 2000
Applicant
R.H. BURTON CO.
3965 BROOKHAM DR.
P.O. BOX 68
GROVE CITY,  OH  43123
Applicant Contact KEVIN M LOYCHIK
Correspondent
R.H. BURTON CO.
3965 BROOKHAM DR.
P.O. BOX 68
GROVE CITY,  OH  43123
Correspondent Contact KEVIN M LOYCHIK
Regulation Number886.1850
Classification Product Code
HJO  
Date Received09/23/1992
Decision Date 01/27/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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