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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 K060780
Device Name TONOMETER DIATON
Applicant
Ryazan State Instruments
151 E. Walnut St.
Long Beach,  NY  11561
Applicant Contact BORIS KUN
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact NEIL E DEVINE
Regulation Number886.1930
Classification Product Code
HKX  
Date Received03/22/2006
Decision Date 04/06/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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