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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tonometer, Ac-Powered
510(k) Number K924777
Device Name BURTON APPLANATION TONOMETER - MODEL T850 & T1000
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 Number886.1930
Classification Product Code
HKX  
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
Predetermined Change
Control Plan Authorized		 No
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