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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmoscope, Ac-Powered
510(k) Number K031312
Device Name RTA MODEL D RETINAL THICKNESS ANALYZER
Applicant
Talia Technology , Ltd.
555 Thirteenth St., NW
Washington,  DC  20004 -1109
Applicant Contact JONATHAN S KAHN
Correspondent
Talia Technology , Ltd.
555 Thirteenth St., NW
Washington,  DC  20004 -1109
Correspondent Contact JONATHAN S KAHN
Regulation Number886.1570
Classification Product Code
HLI  
Date Received04/24/2003
Decision Date 05/06/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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