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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tonometer, Manual
510(k) Number K032769
Device Name EYESOPEN TONOMETER
Applicant
Eye-Deas, LLC
39 Sandringham Rd.
Rochester,  NY  14610
Applicant Contact STEVEN E FELDON
Correspondent
Citech
5200 Butler Pike
Plymouth Meeting,  PA  19462 -1298
Correspondent Contact ERIN SPARNON
Regulation Number886.1930
Classification Product Code
HKY  
Date Received09/08/2003
Decision Date 09/23/2003
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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