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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 K920571
Device Name TRIAL LENS SET
Applicant
R.H. BURTON CO.
3965 BROOKHAM DR.
P.O. BOX 68
GROVE CITY,  OH  43123
Applicant Contact TAMMY DERN
Correspondent
R.H. BURTON CO.
3965 BROOKHAM DR.
P.O. BOX 68
GROVE CITY,  OH  43123
Correspondent Contact TAMMY DERN
Regulation Number886.1405
Classification Product Code
HPC  
Date Received02/07/1992
Decision Date 05/07/1992
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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