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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 K000731
Device Name MODIFICATION TO RTA RETINAL THICKNESS ANALYZER
Applicant
TALIA TECHNOLOGY LTD.
COLUMBIA SQUARE
555 THIRTEENTH STREET N.W.
WASHINGTON,  DC  20004 -1109
Applicant Contact JONATHAN S KAHAN
Correspondent
TALIA TECHNOLOGY LTD.
COLUMBIA SQUARE
555 THIRTEENTH STREET N.W.
WASHINGTON,  DC  20004 -1109
Correspondent Contact JONATHAN S KAHAN
Regulation Number886.1570
Classification Product Code
HLI  
Date Received03/06/2000
Decision Date 03/31/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Special
Reviewed by Third Party No
Combination Product No
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