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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Lens, Trial, Ophthalmic
510(k) Number K924786
Device Name BURTON TRIAL LENS SET
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 Number886.1405
Classification Product Code
HPC  
Date Received09/23/1992
Decision Date 04/14/1993
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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