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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stand, instrument, ac-powered, ophthalmic
510(k) Number K924771
Device Name BURTON OPHTHALMIC STAND - MODEL XL3200
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 Number886.1860
Classification Product Code
HMF  
Date Received09/23/1992
Decision Date 04/05/1993
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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